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Unicryl

FDA UDI

Class II (US FDA UDI)

by United Medical Industries Co. Ltd

Identity

Trade Name
UNICRYL FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
Braided Coated Polyglycolic Acid (PGA) Synthetic Absorbable Surgical Sutures / Ligatures. FDA UDI
Model / Reference
DW8515 FDA UDI
Description
Braided Coated Polyglycolic Acid (PGA) Synthetic Absorbable Surgical Sutures / Ligatures. FDA UDI

Identifiers

Catalog Number
DW8515 FDA UDI
Primary DI / UDI-DI
16285379148817 FDA UDI
510(k) Number
K042288 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 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 — 0.4 Millimeter FDA UDI

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Unicryl by United Medical Industries Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Medical Industries Co. Ltd

Sources (1)

  • FDA UDI 7b27cc23-10f9-4dfd-a621-800f0a006990 38 fields · synced May 30, 2026