FDA.reportPublic FDA data

McKesson

Primary DI
20612479283217
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
M-8698G
Device description
SUTURE, POLYPRO 5-0 18" BLU
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
GAGStapler, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172149000FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2017-10-20GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479285062PackageGS124In Commercial Distribution
20612479283217PrimaryGS10
10612479283791Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247928506240612479285062
2061247928321720612479283217
1061247928379110612479283791

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
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
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000378TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000538TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000545TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000576TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000583TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000590TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000606TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27