Identity
- Trade Name
- Advanced Endodontic System FDA UDI
- Generic Name
- Laparoscopic wound closure thread FDA UDI
- Device Name
- Advanced Endodontic System FDA UDI
- Model / Reference
- 90-2125E FDA UDI
- Description
- Advanced Endodontic System FDA UDI
Identifiers
- Catalog Number
- 90-2125E FDA UDI
- Primary DI / UDI-DI
- 00850309007183 FDA UDI
- 510(k) Number
- K123139 FDA UDI
- FDA Product Code
- LQY FDA UDIEKX FDA UDIEKR FDA UDIEFA FDA UDIEBZ FDA UDIDZI FDA UDIEIA FDA UDIELC FDA UDI
- GMDN Term
- Laparoscopic wound closure thread FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.4200 FDA UDI872.4565 FDA UDI872.6070 FDA UDI872.4120 FDA UDI872.6640 FDA UDI872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laparoscopic wound closure thread
Advanced Endodontic System by Asi Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic wound closure thread.
- Monopolar posts long for handles — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
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- Carter-Thomason CloseSure System® — CooperSurgical, Inc. · Class II
- Retrieval Pouch (Multi Deploy) 15mm — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- 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
- Trocar Swab Kit — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Cleared under the same submission
K123139 also covers:
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, INC.
- Advanced Dental System — ASI MEDICAL, 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 U | Pending data |
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Manufacturer
- Manufacturer
- Asi Medical, Inc.
Sources (1)
- FDA UDI c082e56e-9373-4eb9-8c69-c386c6162884 36 fields · synced May 30, 2026