MONOCRYL

Primary DI
30705031465255
Brand
MONOCRYL
Company
ETHICON, LLC
Model
Y4946H
Catalog number
Y4946H
Device description
Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Published
2021-02-19
Public version status
New
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
30705031465255PackageGS136In Commercial Distribution
10705031465251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503146525530705031465255
1070503146525110705031465251

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 device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079402290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031097889ETHIBOND EXCELEH7755HEH7755H2026-07-17
10705031102996ETHIBOND EXCELPE6680HPE6680H2026-07-17
10705031103085ETHIBOND EXCELPE7055HPE7055H2026-07-17
10705031238404ETHIBOND EXCELW975GW975G2026-07-17
10705031461963ETHIBOND EXCELW979GW979G2026-07-17
10705031461970ETHIBOND EXCELX32039HX32039H2026-07-17
10705031472143Coated VICRYLVCP814DVCP814D2026-05-08
10705031472174MONOCRYLMCP2543GMCP2543G2026-05-08
10705031472181MONOCRYLMCP507GMCP507G2026-05-08
10705031472198MONOCRYLMCP895HMCP895H2026-05-08
10705031024748ETHILOND3116D31162015-09-23
10705031026643ETHILOND6661D66612015-09-23
10705031027084ETHILOND7018D70182015-09-23
10705031030138ETHILOND8420D84202015-09-23
10705031030558ETHILOND8555D85552015-09-23
10705031032743ETHILOND9336D93362015-09-23
10705031033474ETHILOND9537D95372015-09-23
10705031148161ETHICONESS15ESS152015-09-24
10705031001589ETHILON1647G1647G2015-09-01
10705031002050ETHILON1683H1683H2015-09-01

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