FDA.reportPublic FDA data

Softcat

Primary DI
04045439002962
Brand
Softcat
Company
B BRAUN SURGICAL SA
Model
G0668654
Catalog number
G0668654
Device description
SOFTCAT CHROM 4/0 (2) 45CM 2XHLM8 (M)
Published
2015-08-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GALSUTURE, ABSORBABLE, NATURAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045439002962PrimaryGS10
04046963057152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045439002962040454390029624045439002962
04046963057152040469630571524046963057152

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length45Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
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
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
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506795Bioviva by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAL2026-03-05
00841336100442Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
10841336117621Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
10841336117638Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
10841336117782Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
10841336117805Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
10841336117829Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
00841336117822Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAL2025-09-28
D765GC3019451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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
D765GP3022451X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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
10889813064686Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27
10889813064693Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27
10889813064709Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27
10889813064723Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27
10889813064730Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCGAL2025-06-27