FDA.reportPublic FDA data

McKesson

Primary DI
20612479283392
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
M-J496G
Device description
SUTURE, VELOCRIL 4-0 18" UD
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172659000MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical SutureM/s. Meril Endo Surgery Private Limited.2017-09-28GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479285376PackageGS124In Commercial Distribution
20612479283392PrimaryGS10
10612479283975Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247928537640612479285376
2061247928339220612479283392
1061247928397510612479283975

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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.

Regulatory Flags#

DUNS number
023904428
Device count
12
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26
20612479284597McKessonM-9000G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479283385McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283408McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283415McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285303McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285327McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285341McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285389McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285402McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285426McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285440McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285464McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285488McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285518McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285532McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285563McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285594McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285617McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285631McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285655McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285679McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285693McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
00840277412010ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
00840277412027ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
10810020085218HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411768HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411775HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411782HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411799HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
00840277411808HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
03661522100837CARDIOXYL®PETERS SURGICALGAT2026-03-09