FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040039588
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700463
Catalog number
5700463
Device description
Suture PGA PCL Mono DSM24
Published
2017-01-10
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040039585PackageGS112In Commercial Distribution
00304040039588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404003958510304040039585
00304040039588003040400395883040400395880304040039588

GMDN Terms#

Term, Definition table
TermDefinition
Poliglecaprone sutureA sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046963535797NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535810NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535995NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536176NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536213NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535438NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535537NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535636NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535674NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534578NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534752NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534776NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534998NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535278NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535315NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535339NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535391NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535575NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535698NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535971NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536015NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536138NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536190NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536251NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536275NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536312NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536350NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536596NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536695NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536770NovosynB BRAUN SURGICAL SAGAM2015-08-12