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DemeCRYL

FDA UDI

Class II (US FDA UDI)

by DemeTECH Corp

Identity

Trade Name
DemeCRYL FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
Synthetic (polyglactin 910) , Absorbable Suture FDA UDI
Model / Reference
G1082026F2P FDA UDI
Description
Synthetic (polyglactin 910) , Absorbable Suture FDA UDI

Identifiers

Primary DI / UDI-DI
10652927785323 FDA UDI
510(k) Number
K043539 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

DemeCRYL is a synthetic absorbable suture made from polyglactin 910, designed for general plastic surgery applications. This device is labeled as approved for use in the United States and meets FDA regulations. Its sterilization method ensures user safety and compliance with regulatory requirements.

Similar devices

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

Cleared under the same submission

K043539 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DemeTECH Corp

Sources (1)

  • FDA UDI 5ebf8eac-5df9-44ad-a2db-0c5e1ec13763 36 fields · synced Aug 4, 2026