Identity
- Trade Name
- PMI FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- PMI Disposable 15mm 4-Hole Bariatric Suture Guide FDA UDI
- Model / Reference
- PMI154D FDA UDI
- Description
- PMI Disposable 15mm 4-Hole Bariatric Suture Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812608021895 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Laparoscopic wound closure thread 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: Laparoscopic wound closure thread
Pmi by Progressive Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic wound closure thread.
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- Carter-Thomason CloseSure System® — CooperSurgical, Inc. · Class II
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- Advanced Endodontic System — ASI MEDICAL, INC. · U
- neoClose 2 AutoAnchor Pack US — Neosurgical, Ltd. · Class II
- Lap Port Closure Device Bariatric Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- Carter-Thomason (REGARD Distributed) — CooperSurgical, Inc. · 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
- Progressive Medical, Inc.
Sources (1)
- FDA UDI 0beadf69-7a65-4774-99c6-09e02b2dd012 33 fields · synced May 30, 2026