Identity
- Trade Name
- SMARTSTITCH M-CONNECTOR FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- SMARTSTITCH M-CONNECTOR PKG. ASS FDA UDI
- Model / Reference
- OM-8007 FDA UDI
- Description
- SMARTSTITCH M-CONNECTOR PKG. ASS FDA UDI
Identifiers
- Catalog Number
- OM-8007 FDA UDI
- Primary DI / UDI-DI
- 00817470005714 FDA UDI
- 510(k) Number
- K123268 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing unit, reusable
Smartstitch M-Connector by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, reusable.
- Hip Suture Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Suture Manipulator Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Knot Manipulator Full Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
Cleared under the same submission
K123268 also covers:
- PERFECTPASSER — Smith & Nephew, Inc.
- SMARTSTITCH — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH M-CONNECTOR — Smith & Nephew, Inc.
- SMARTSTITCH PERFECTPASSER — Smith & Nephew, Inc.
- SMARTSTITCH PERFECTPASSER — Smith & Nephew, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI f332f8ee-6219-49d0-b7ab-3ecf6ee41dc8 36 fields · synced Jun 8, 2026