FDA.reportPublic FDA data

OsteoFab Suture Anchor

Primary DI
00850004435021
Brand
OsteoFab Suture Anchor
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
INS002-01-002
Device description
3mm OsteoFab Suture Anchor Awl
Published
2020-01-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004435021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004435021008500044350218500044350210850004435021

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-860-698-9300CustomerService@oxfordpm.com

Regulatory Flags#

DUNS number
962301359
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188325457HTR-PEKKPK6274052026-09-04
00810188325464HTR-PEKKPK6274072026-09-04
00810188325303HTR-PEKKPK6273922026-08-26
00810188325372HTR-PEKKPK6273992026-08-26
00810188325389HTR-PEKKPK6274002026-08-26
00810188325327HTR-PEKKPK6273942026-08-19
00810188325334HTR-PEKKPK6273952026-08-19
00810188325297HTR-PEKKPK6273912026-08-17
00810188325259HTR-PEKKPK6273842026-08-07
00810188325266HTR-PEKKPK6273852026-08-07
00810188325044HTR-PEKKPK6273702026-08-03
00810188325181HTR-PEKKPK6273732026-08-03
00810188325204HTR-PEKKPK6273802026-08-03
00810188325174HTR-PEKKPK6273792026-07-31
00850004435007OsteoFab Suture AnchorINS002-02-0012020-01-16
00850004435014OsteoFab Suture AnchorINS002-01-0012020-01-16
00850004435038OsteoFab Suture AnchorINS002-01-0032020-01-16
00850004435045OsteoFab Suture AnchorSA002-452020-01-16
00850004435052OsteoFab Suture AnchorSA002-552020-01-16
00850004435069OsteoFab Suture AnchorSA002-652020-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
04054896000770AwlSilony Medical GmbHHWJ2026-09-18
04054896000787AwlSilony Medical GmbHHWJ2026-09-18
04054896002927AwlSilony Medical GmbHHWJ2026-09-18
04054896005553AwlSilony Medical GmbHHWJ2026-09-18
04054896005560AwlSilony Medical GmbHHWJ2026-09-18
04054896005577AwlSilony Medical GmbHHWJ2026-09-18
04054896014999AwlSilony Medical GmbHHWJ2026-09-18
04054896015002AwlSilony Medical GmbHHWJ2026-09-18
04054896021669AwlSilony Medical GmbHHWJ2026-09-18
04054896024288AwlSilony Medical GmbHHWJ2026-09-18
04054896024295AwlSilony Medical GmbHHWJ2026-09-18
04054896024301AwlSilony Medical GmbHHWJ2026-09-18
04054896024318AwlSilony Medical GmbHHWJ2026-09-18
04054896032818AwlSilony Medical GmbHHWJ2026-09-18
04054896052595AwlSilony Medical GmbHHWJ2026-09-18
04054896052601AwlSilony Medical GmbHHWJ2026-09-18
04054896056777AwlSilony Medical GmbHHWJ2026-09-18
04054896069289AwlSilony Medical GmbHHWJ2026-09-18
04054896079325AwlSilony Medical GmbHHWJ2026-09-18
04054896079332AwlSilony Medical GmbHHWJ2026-09-18
04054896079349AwlSilony Medical GmbHHWJ2026-09-18
04054896079356AwlSilony Medical GmbHHWJ2026-09-18
04054896079363AwlSilony Medical GmbHHWJ2026-09-18
04054896079370AwlSilony Medical GmbHHWJ2026-09-18
04054896079387AwlSilony Medical GmbHHWJ2026-09-18
04054896079394AwlSilony Medical GmbHHWJ2026-09-18
04054896079578AwlSilony Medical GmbHHWJ2026-09-18
04054896079585AwlSilony Medical GmbHHWJ2026-09-18
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03