Needle Length (m) 25.40 mm
Needle Tip Type BD Nokor
Needle Type Fill
Needle Wall Type Thin wall
Total Shelf Life 1825
Sterile Sterilized product
Type Of Bevel BD Nokor
Sterilization Method Radiation
BPA Free Not made with BPA
DEHP Free Not made with DEHP
Latex Statement Not made with natural rubber latex
PVC Free Not made with PVC
Disposable Disposable product
Single Use Product is for single use only
Regulatory Compliance and Quality System
BD Products comply with the regulatory requirements of the region in which these are sold and manufactured.
Sterility
All products which are labeled as #sterile# and released for sale by BD are certified to be sterile as long as the package is unopened and undamaged. For those products labeled #sterile fluid path#, only the fluid path is sterile. This product is primarily sterilized via Gamma radiation. Sterilization cycle development/validation is performed to 10-6SAL in accordance with current ISO 11137 guidelines.
Biocompatability
This product has been evaluated in accordance with ISO 10993 "Biological Evaluation of Medical Devices", and complies with all relevant sections.
Quality Control Testing and Release
Representative production samples are collected and inspected in accordance with current applicable product specifications. Inspection records are reviewed and signed off by qualified personnel for product release. The released devices meet applicable BD product specifications.
Device Characteristics
What MRI safety information does the labeling contain? Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) No
Device labeled as "Not made with natural rubber latex" No
For Single-Use Yes
Prescription Use (Rx) Yes
Over the Counter (OTC) No
Kit No
Combination Product No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) No
Product Packaging Information
Packaging Level Shelfpack Each Case
Quantity 100 1 1000
Length 11.6 cm 451.0 mm
Width 9.0 cm 181.0 mm
Height 8.6 cm 129.0 mm
Weight 123.2 g 1.232 g 1.232 kg