Identity
- Trade Name
- UNIMIDE C FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Sheathed, Polyamide, Synthetic, Non-absorbable Surgical Sututres / Ligatures FDA UDI
- Model / Reference
- DW3742 FDA UDI
- Description
- Sheathed, Polyamide, Synthetic, Non-absorbable Surgical Sututres / Ligatures FDA UDI
Identifiers
- Catalog Number
- DW3742 FDA UDI
- Primary DI / UDI-DI
- 16285379148916 FDA UDI
- 510(k) Number
- K042284 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.2 Millimeter FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
Unimide C by United Medical Industries Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
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Cleared under the same submission
K042284 also covers:
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
- United Medical Industries Co. Ltd
Sources (1)
- FDA UDI bf3f6781-6991-42fd-981b-7c5cd0d88126 38 fields · synced May 31, 2026