FDA.reportPublic FDA data

MONOCRYL

Primary DI
10705031046566
Brand
MONOCRYL
Company
ETHICON, LLC
Model
MCP493G
Catalog number
MCP493G
Device description
Antibacterial Undyed 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050845000
K201996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050845000MONOCRYL PLUS ANTIBACTERIAL SUTUREETHICON, Inc.2005-06-29GAM
K201996000Monocryl Plus Antibacterial SutureETHICON, Inc.2020-12-21GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031046560PackageGS112In Commercial Distribution
10705031046566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503104656030705031046560
1070503104656610705031046566

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 needle. It is not a barbed suture. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
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
00814639025606UNIFY PGA Surgical SuturesAPPLIED DENTAL, INC.GAM2026-07-17
00848782052493SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
00848782052509SharpointSurgical Specialties México, S. de R.L. de C.V.GAM2026-07-06
17891338994365VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994389VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994396VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994440VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994457VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994501VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994532VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994556VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994563VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994570VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994839VICRYL RAPIDEETHICON, LLCGAM2026-07-03
17891338994860VICRYL RAPIDEETHICON, LLCGAM2026-07-03
00840277412065ViletRIVERPOINT MEDICAL, LLCGAM2026-06-08
10705031472143Coated VICRYLETHICON, LLCGAM2026-05-08
10705031472174MONOCRYLETHICON, LLCGAM2026-05-08
10705031472181MONOCRYLETHICON, LLCGAM2026-05-08
10705031472198MONOCRYLETHICON, LLCGAM2026-05-08
08904255257412PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257443PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257450PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257467PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257474PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257481PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255234369PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234376PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234390PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04