OsteoFab Suture Anchor

GUDID 00850004435069

OsteoFab 6.5mm Suture Anchor

OXFORD PERFORMANCE MATERIALS, INC.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00850004435069
NIH Device Record Key2bbcbbed-1edd-4431-88c6-70dd97d900d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoFab Suture Anchor
Version Model NumberSA002-65
Company DUNS962301359
Company NameOXFORD PERFORMANCE MATERIALS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004435069 [Primary]
GS100850004435090 [Package]
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850004435069]

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

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