Identity
- Trade Name
- Myo/Wire II FDA UDI
- Generic Name
- Metallic suture, monofilament FDA UDI
- Device Name
- SS Suture, 5 per sleeve FDA UDI
- Model / Reference
- 040-412 FDA UDI
- Description
- SS Suture, 5 per sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841291102205 FDA UDI
- 510(k) Number
- K932513 FDA UDI
- FDA Product Code
- GAO FDA UDI
- GMDN Term
- Metallic suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4495 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metallic suture, monofilament
Myo/Wire II by A & E Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic suture, monofilament.
- DemeSTEEL — DemeTECH Corp · Class II
- ACIER — PETERS SURGICAL · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- ACIER — PETERS SURGICAL · Class II
Cleared under the same submission
K932513 also covers:
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
- Myo/Wire II — A & E MEDICAL CORPORATION
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
- A & E Medical Corporation
Sources (1)
- FDA UDI c151daa8-0428-4338-b45a-c8ab242aa7e9 34 fields · synced Jun 1, 2026