Identity
- Trade Name
- UNICRYL M FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures. FDA UDI
- Model / Reference
- SD10036 FDA UDI
- Description
- Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures. FDA UDI
Identifiers
- Catalog Number
- SD10036 FDA UDI
- Primary DI / UDI-DI
- 16285379148848 FDA UDI
- 510(k) Number
- K042285 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 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: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Unicryl M by United Medical Industries Co. Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 90c369de-39a4-4904-bb27-3e20d318fb98 38 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026