FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040000469
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
900-7468
Catalog number
900-7468
Device description
HS C3 6-0 UND BR PGA 18"/45CM
Published
2015-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20304040000469PackageGS112In Commercial Distribution
00304040000465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404000046920304040000469
00304040000465003040400004653040400004650304040000465

GMDN Terms#

Term, Definition table
TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
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
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747457Polyglactin 910HEALTHIUM MEDTECH LIMITEDGAM2026-05-25
00810126508331Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508348Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
10817169023019Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00817169023005Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508232Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508249Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508256Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508263Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
03661522100189OPTIME®PETERS SURGICALGAM2026-03-09
03661522100196OPTIME®PETERS SURGICALGAM2026-03-09
03661522100219OPTIME®PETERS SURGICALGAM2026-03-09
03661522100714OPTIME®PETERS SURGICALGAM2026-03-09
03661522100721OPTIME®PETERS SURGICALGAM2026-03-09
03661522100738OPTIME®PETERS SURGICALGAM2026-03-09
03661522100752OPTIME®PETERS SURGICALGAM2026-03-09
03661522100868OPTIME®PETERS SURGICALGAM2026-03-09
03661522100875OPTIME®PETERS SURGICALGAM2026-03-09
03661522101414OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101421OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101438OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101445OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101452OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101469OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101476OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101483OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101490OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101506OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101513OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101575OPTIME®PETERS SURGICALGAM2026-03-09