OsteoFab Suture Anchor

GUDID 00850004435038

4mm OsteoFab Suture Anchor Awl

OXFORD PERFORMANCE MATERIALS, INC.

Bone awl
Primary Device ID00850004435038
NIH Device Record Key659e1bf3-2dbb-4032-baf6-7324d01c1d30
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFab Suture Anchor
Version Model NumberINS002-01-003
Company DUNS962301359
Company NameOXFORD PERFORMANCE MATERIALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com
Phone1-860-698-9300
EmailCustomerService@oxfordpm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004435038 [Primary]

FDA Product Code

HWJAwl

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


[00850004435038]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-24
Device Publish Date2020-01-16

On-Brand Devices [OsteoFab Suture Anchor]

00850004435069OsteoFab 6.5mm Suture Anchor
00850004435052OsteoFab 5.5mm Suture Anchor
00850004435045OsteoFab 4.5mm Suture Anchor
008500044350384mm OsteoFab Suture Anchor Awl
008500044350213mm OsteoFab Suture Anchor Awl
008500044350142mm OsteoFab Suture Anchor Awl
00850004435007OsteoFab Suture Anchor Inserter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.