FDA.reportPublic FDA data

CHROMIC GUT

Primary DI
10790986006840
Brand
CHROMIC GUT
Company
C.P. MEDICAL CORPORATION
Model
635CG
Catalog number
635CG
Device description
*FOR EVALUATION PURPOSES ONLY*
Published
2016-11-17
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
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
10790986006840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1079098600684010790986006840

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, 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 table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
807404611
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00790986000001CP Cotton Umbilical TapeCP10A2024-03-29
00790986000551CP Cotton Umbilical TapeCP11A2015-09-24
00790986000568CP Cotton Umbilical TapeCP12A2015-09-24
20790986000555CP Cotton Umbilical TapeCP11A2015-09-24
20790986006298FN NEEDLESFN18-51TFN18-51T2016-02-19
20790986006304FN NEEDLESFN18-3TFN18-3T2016-02-19
20790986006311FN NEEDLESFN18-1TFN18-1T2016-02-19
20790986006328FN NEEDLESFN17-51TFN17-51T2016-02-19
20790986006335FN NEEDLESFN17-3TFN17-3T2016-02-19
20790986006342FN NEEDLESFN17-1TFN17-1T2016-02-19
20790986006878FN NEEDLESFN18-53T2017-11-06
10790986001005MONO-DOXM1842016-07-26
20790986001019MONO-DOXM3042016-07-26
20790986001026MONO-DOXM305M3052016-06-13
20790986001033MONO-DOXM310M3102016-06-13
20790986001040MONO-DOXM311M3112016-06-13
20790986001057MONO-DOXM3152016-07-26
20790986001071MONO-DOXM317M3172016-07-26
20790986001088MONO-DOXM332M3322016-06-13
20790986001095MONO-DOXM333M3332016-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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