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Monocryl

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
MONOCRYL FDA UDI
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Device Name
Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture FDA UDI
Model / Reference
D8694 FDA UDI
Description
Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture FDA UDI

Identifiers

Catalog Number
D8694 FDA UDI
Primary DI / UDI-DI
10705031030961 FDA UDI
510(k) Number
K964072 FDA UDI
FDA Product Code
GAN FDA UDI
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4830 FDA UDI
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, monofilament, non-antimicrobial

Monocryl by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K964072 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI d8b9aba4-0350-49b4-912a-d74bf7be7f70 36 fields · synced May 30, 2026