FDA.reportPublic FDA data

MONOCRYL

Primary DI
10705031471832
Brand
MONOCRYL
Company
ETHICON, LLC
Model
MCP957H
Catalog number
MCP957H
Device description
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, absorbable, synthetic, polyglycolic acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201996000Monocryl Plus Antibacterial SutureETHICON, Inc.2020-12-21GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031471836PackageGS136In Commercial Distribution
10705031471832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503147183630705031471836
1070503147183210705031471832

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester and containing an agent to locally inhibit bacterial growth, intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
079402290
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031064669MERSILENEF1506F15062026-08-25
10705031064683MERSILENEF1532F15322026-08-25
10705031064706MERSILENEF1534F15342026-08-25
10705031064805MERSILENEF2502F25022026-08-25
10705031064812MERSILENEF2503F25032026-08-25
10705031064904MERSILENEF2515F25152026-08-25
10705031064959MERSILENEF2520F25202026-08-25
10705031064973MERSILENEF2525F25252026-08-25
10705031065185MERSILENEF2570F25702026-08-25
10705031065369MERSILENEFR832FR8322026-08-25
10705031089020ETHILON2871G2871G2026-08-25
10705031096479ETHILONEH7436GEH7436G2026-08-25
10705031097421MERSILENEEH7638HEH7638H2026-08-25
10705031097599MERSILENEEH7684HEH7684H2026-08-25
10705031097865MERSILENEEH7750HEH7750H2026-08-25
10705031241060MERSILENEF1533HF1533H2026-08-25
10705031241077MERSILENEF2506HF2506H2026-08-25
10705031241107MERSILENEF2514HF2514H2026-08-25
10705031241114MERSILENEF2516HF2516H2026-08-25
10705031241138MERSILENEF2520HF2520H2026-08-25

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10884521840720TrexonCovidien LPGAM2026-10-10