FDA.reportPublic FDA data

MONOCRYL

Primary DI
10705031046856
Brand
MONOCRYL
Company
ETHICON, LLC
Model
MCPB345H
Catalog number
MCPB345H
Device description
Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Published
2015-09-01
Public version status
Update
Distribution status
Not 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
K050845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050845000MONOCRYL PLUS ANTIBACTERIAL SUTUREETHICON, Inc.2005-06-29GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031046850PackageGS136Not in Commercial Distribution
10705031046856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503104685030705031046850
1070503104685610705031046856

GMDN Terms#

Term, Definition table
TermDefinition
Poliglecaprone suture, antimicrobialA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. 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
10705031001435ETHILON1629H1629H2015-09-01
10705031006393ETHILON585H585H2015-09-01
10705031007703ETHILON661H661H2015-09-01
10705031007789ETHILON663H663H2015-09-01
10705031007918ETHILON669H669H2015-09-01
10705031008724PERMA-HAND706G706G2015-09-01
10705031129931ETHICONW945W9452026-05-18
10705031239777ETHIBOND EXCELX4B37GX4B37G2018-01-25
10705031239784ETHIBOND EXCELX4B77GX4B77G2018-01-31
10705031462144ETHIBOND EXCEL10X52N10X52N2019-07-04
10705031462168ETHIBOND EXCEL10X72N10X72N2019-07-04
10705031462175ETHIBOND EXCEL10X66N10X66N2019-07-04
10705031468214ETHIBOND EXCELD7576ND7576N2021-05-08
10705031468221ETHIBOND EXCELD10048ND10048N2021-05-08
10705031468238ETHIBOND EXCELD7581ND7581N2021-05-08
10705031468245ETHIBOND EXCELD7924ND7924N2021-05-08
10705031468276ETHIBOND EXCELD8492ND8492N2021-05-08
10705031468320ETHIBOND EXCELD9079ND9079N2021-05-08
10705031468344ETHIBOND EXCELD9329ND9329N2021-05-08
10705031468351ETHIBOND EXCELD9607ND9607N2021-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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