FDA.reportPublic FDA data

Coated VICRYL

Primary DI
10705031056237
Brand
Coated VICRYL
Company
ETHICON, LLC
Model
VCP959H
Catalog number
VCP959H
Device description
Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K032420000
K132580000
K181652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032420000MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREETHICON, Inc.2003-10-22GAM
K132580000COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREETHICON, Inc.2014-02-28GAM
K181652000Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureETHICON, Inc.2018-09-28GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031056231PackageGS136In Commercial Distribution
10705031056237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503105623130705031056231
1070503105623710705031056237

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, antimicrobialA multiple-strand (multifilament), 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 device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
true
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
10705031051805Coated VICRYLVCP260HVCP260H2015-09-01
10705031051874Coated VICRYLVCP267HVCP267H2015-09-01
10705031051911Coated VICRYLVCP269HVCP269H2015-09-01
10705031053038Coated VICRYLVCP417HVCP417H2015-09-01
10705031055933Coated VICRYLVCP870HVCP870H2015-09-01
10705031056213Coated VICRYLVCP958HVCP958H2015-09-01
10705031051744Coated VICRYLVCP232HVCP232H2015-09-01
10705031052475Coated VICRYLVCP339HVCP339H2015-09-01
10705031052499Coated VICRYLVCP340HVCP340H2015-09-01
10705031052635Coated VICRYLVCP352HVCP352H2015-09-01
10705031053823Coated VICRYLVCP497HVCP497H2015-09-01
10705031056114Coated VICRYLVCP944HVCP944H2015-09-01
10705031056121Coated VICRYLVCP945HVCP945H2015-09-01
10705031056145Coated VICRYLVCP946HVCP946H2015-09-01
10705031053519Coated VICRYLVCP468HVCP468H2015-09-01
10705031097889ETHIBOND EXCELEH7755HEH7755H2026-07-17
10705031102996ETHIBOND EXCELPE6680HPE6680H2026-07-17
10705031103085ETHIBOND EXCELPE7055HPE7055H2026-07-17
10705031238404ETHIBOND EXCELW975GW975G2026-07-17
10705031461963ETHIBOND EXCELW979GW979G2026-07-17

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