FDA UDI In Commercial Distribution 🇺🇸 United States

GMReis Suture Anchors

DI: 07899258662374 · Model: FASTLOCK - KNOTLESS PEEK ANCHOR Ø3.5x10.1/15.8mm WITH CLOSED EYELET · GM DOS REIS INDUSTRIA E COMERCIO LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GMReis Suture Anchors
Primary DI
07899258662374
Version / Model
FASTLOCK - KNOTLESS PEEK ANCHOR Ø3.5x10.1/15.8mm WITH CLOSED EYELET
Catalog Number
320-351580-PE3
Company Name
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Labeler DUNS
900865213
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-09
Public Version
1
Public Version Date
2025-12-17
Public Version Status
New
Public Device Record Key
c9d30e9b-87fa-49c7-bdac-284179c84295

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
Yes

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MBI Fastener, Fixation, Nondegradable, Soft Tissue

GMDN Terms

Code Name
45062 Tendon/ligament bone anchor, non-bioabsorbable

Identifiers

Type ID
Primary 07899258662374