FDA.report

Karl Schumacher

Primary DI
00842517100565
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
SGT064027
Device description
4-0 Plain Gut,27",C-6 3/8 Cir,Rev Cut,12
Published
2024-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GALSuture, absorbable, natural

Product Code Classifications

CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842517100565PackageGS112In Commercial Distribution
00842517100558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517100565008425171005658425171005650842517100565
00842517100558008425171005588425171005580842517100558

GMDN Terms

TermDefinition
Catgut suture, plainA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags

DUNS number
101070070
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

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10841336117829Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
00841336117822Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
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D765GC3019751X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC3019P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC3019P751X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC4013P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC4019451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC4019751X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC4019P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC5013P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC5016P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC5019451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GP3019451X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GP3019751X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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D765GP3024751X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GP4019451X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GP4019751X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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10889813064723Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27
10889813064730Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27