MONOCRYL

Primary DI
10705031465268
Brand
MONOCRYL
Company
ETHICON, LLC
Model
YB4946H
Catalog number
YB4946H
Device description
Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Published
2021-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GANSUTURE, ABSORBABLE, SYNTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GANSuture, Absorbable, SyntheticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964072000MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.1996-12-18GAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031465262PackageGS136In Commercial Distribution
10705031465268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503146526230705031465262
1070503146526810705031465268

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
10705031472754STRATAFIXSXPN1B402SXPN1B4022026-10-29
10705031472761STRATAFIXSXPN1B404SXPN1B4042026-10-29
10705031472778STRATAFIXSXPN1B409SXPN1B4092026-10-29
10705031472785STRATAFIXSXPN1B411SXPN1B4112026-10-29
10705031472792STRATAFIXSXPN1B413SXPN1B4132026-10-29
10705031472808STRATAFIXSXPN2B400SXPN2B4002026-10-29
10705031472815STRATAFIXSXPN1B400SXPN1B4002026-10-29
10705031472822STRATAFIXSXPN1B403SXPN1B4032026-10-29
10705031472839STRATAFIXSXPN1B412SXPN1B4122026-10-29
10705031472846STRATAFIXSXPN1B401SXPN1B4012026-10-29
10705031472853STRATAFIXSXPN1B410SXPN1B4102026-10-29
10705031472860STRATAFIXSXPN1B408SXPN1B4082026-10-29
10705031472877STRATAFIXSXPN2B402SXPN2B4022026-10-29
10705031472884STRATAFIXSXPN1B405SXPN1B4052026-10-29
10705031472891STRATAFIXSXPN1B406SXPN1B4062026-10-29
10705031472907STRATAFIXSXPN1B407SXPN1B4072026-10-29
10705031472914STRATAFIXSXPN2B403SXPN2B4032026-10-29
10705031472921STRATAFIXSXPN2B404SXPN2B4042026-10-29
10705031472938STRATAFIXSXPN2B405SXPN2B4052026-10-29
10705031472945STRATAFIXSXPN2B406SXPN2B4062026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031463998MONOCRYLETHICON, LLCGAN2023-08-28
10705031470354MONOCRYLETHICON, LLCGAN2023-08-28
10705031470361MONOCRYLETHICON, LLCGAN2023-08-28
10705031470385MONOCRYLETHICON, LLCGAN2023-08-28
10705031470392MONOCRYLETHICON, LLCGAN2023-08-28
10705031059764MONOCRYLETHICON, LLCGAN2023-05-17
10705031135017MONOCRYLETHICON, LLCGAN2023-05-17
10705031135024MONOCRYLETHICON, LLCGAN2023-05-17
10705031135031MONOCRYLETHICON, LLCGAN2023-05-17
07757093001539SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001553SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001560SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001621SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001638SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001652SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001683SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001829SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001898SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001959SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001973SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001997SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002017SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002093SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002123SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218449SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218562SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218586SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093645238SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002253SUTUMEDUnilene S.A.C.GAN2023-01-08
07757093002284SUTUMEDUnilene S.A.C.GAN2023-01-08