Identity
- Trade Name
- ACCESS FIT FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- ACCESS FIT – STRAIGHT SUTURE PASSER FDA UDI
- Model / Reference
- STRAIGHT SUTURE PASSER FDA UDI
- Description
- ACCESS FIT – STRAIGHT SUTURE PASSER FDA UDI
Identifiers
- Catalog Number
- 359-200 FDA UDI
- Primary DI / UDI-DI
- 07899258663241 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Suturing unit, reusable
Access Fit by Gm Dos Reis Industria E Comercio Ltda — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HAT-TRICK — Smith & Nephew, Inc. · Class I
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 889ee4dd-a882-4a99-8c09-798c83faa6cb 34 fields · synced Jun 6, 2026