FDA.reportPublic FDA data

MONOCRYL

Primary DI
10705031059993
Brand
MONOCRYL
Company
ETHICON, LLC
Model
Y967H
Catalog number
Y967H
Device description
Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Published
2015-09-01
Public version status
Update
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
GANSUTURE, ABSORBABLE, SYNTHETIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960653000MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.1996-03-28GAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031059997PackageGS136In Commercial Distribution
10705031059993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503105999730705031059997
1070503105999310705031059993

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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 needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031047990PDSPDP310HPDP310H2015-09-01
10705031048003PDSPDP311HPDP311H2015-09-01
10705031048058PDSPDP332HPDP332H2015-09-01
10705031048140PDSPDP352HPDP352H2015-09-01
10705031048157PDSPDP353HPDP353H2015-09-01
10705031048201PDSPDP371TPDP371T2015-09-01
10705031048218PDSPDP397HPDP397H2015-09-01
10705031048225PDSPDP398HPDP398H2015-09-01
10705031048331PDSPDP452HPDP452H2015-09-01
10705031048348PDSPDP463GPDP463G2015-09-01
10705031048362PDSPDP467HPDP467H2015-09-01
10705031048492PDSPDP534TPDP534T2015-09-01
10705031048508PDSPDP535HPDP535H2015-09-01
10705031048584PDSPDP695HPDP695H2015-09-01
10705031048683PDSPDP968HPDP968H2015-09-01
10705031048706PDSPDP970HPDP970H2015-09-01
10705031048737PDSPDPB316HPDPB316H2015-09-01
10705031048744PDSPDPB317HPDPB317H2015-09-01
10705031048751PDSPDPB332HPDPB332H2015-09-01
10705031048768PDSPDPB333HPDPB333H2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046963535797NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535810NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535995NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536176NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536213NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535438NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535537NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535636NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535674NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534578NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534752NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534776NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534998NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535278NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535315NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535339NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535391NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535575NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535698NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535971NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536015NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536138NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536190NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536251NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536275NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536312NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536350NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536596NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536695NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536770NovosynB BRAUN SURGICAL SAGAM2015-08-12