Identity
- Trade Name
- Sequel Medical FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Foot Ring Long 180 mm FDA UDI
- Model / Reference
- IM13400180A FDA UDI
- Description
- Foot Ring Long 180 mm FDA UDI
Identifiers
- Catalog Number
- IM13400180A FDA UDI
- Primary DI / UDI-DI
- 00810071321641 FDA UDI
- FDA Product Code
- KTT FDA UDIJDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: External orthopaedic fixation system, single-use
Sequel Medical by Sequel Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
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- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sequel Medical, Inc.
Sources (1)
- FDA UDI 71f43e7b-d942-4d8f-a386-2f0a4045be55 35 fields · synced Jun 1, 2026