Identity
- Trade Name
- Meniscus Suture - OUT IN FDA UDI
- Generic Name
- Meniscus suture anchor FDA UDI
- Device Name
- Meniscus Suture - Out in 424 x 30 x 25mm FDA UDI
- Model / Reference
- Meniscus Suture - OUT IN FDA UDI
- Description
- Meniscus Suture - Out in 424 x 30 x 25mm FDA UDI
Identifiers
- Catalog Number
- 354-100-050 FDA UDI
- Primary DI / UDI-DI
- 07899258658292 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Meniscus suture anchor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Meniscus suture anchor
Meniscus Suture - OUT IN by Gm Dos Reis Industria E Comercio Ltda — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Meniscus suture anchor.
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Down — HEALTHIUM MEDTECH LIMITED · Class II
- MENIX — S.B.M · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Left — HEALTHIUM MEDTECH LIMITED · Class II
- MENIX DUO — S.B.M · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-UP — HEALTHIUM MEDTECH LIMITED · Class II
- SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right — HEALTHIUM MEDTECH LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI dff6bcfa-1888-4e19-9aca-216970bb8eaf 34 fields · synced May 30, 2026