FDA.report

RELI®

Primary DI
20386120010001
Brand
RELI®
Company
MYCO MEDICAL SUPPLIES INC.
Model
GC636-M
Catalog number
GC636-M
Device description
REDIGUT CHROMIC PRO NAT 3-0 YFS-2 30"
Published
2019-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GALSuture, Absorbable, Natural

Product Code Classifications

CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10386120010004PackageGS112In Commercial Distribution
20386120010001PackageGS130In Commercial Distribution
00386120010007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612001000410386120010004
2038612001000120386120010001
00386120010007003861200100073861200100070386120010007

GMDN Terms

TermDefinition
Catgut suture, plainA sterile, 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 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 enzymatic degradation. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length30Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Recommended to be stored below 86°F (30°C), away from moisture and direct heat.

Sterilization Methods

Method

Regulatory Flags

DUNS number
879187821
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10386120014224RELI®SBCS21G-122026-02-02
10386120014231RELI®SBCS23G-122026-02-02
10386120014248RELI®SBCS25G-122026-02-02
10386120013944RELI®PBSBCS21G-122025-07-08
10386120013951RELI®PBSBCS23G-122025-07-08
10386120013968RELI®PBSBCS25G-122025-07-08
10386120013142RELI®PBSBCS21G-122024-11-19
10386120013159RELI®PBSBCS23G-122024-11-19
10386120013166RELI®PBSBCS25G-122024-11-19
10386120013098RELI®PFSS-10ML-SP2024-03-12
10386120013005Wealy® RELI®INSS1ML29G312512023-07-21
10386120013012Wealy® RELI®INSS1ML30G312512023-07-21
10386120012190RELIBTD-MLBTD-ML2023-06-07
10386120012206RELIBTD-FLBTD-FL2023-06-07
10386120012787RELIINSY30G051-S.3MLINSY30G051-S.3ML2023-05-24
10386120012794RELIINSY30G051-S.5MLINSY30G051-S.5ML2023-05-24
10386120012817RELIINSY30G18751-S1MLINSY30G18751-S1ML2023-05-24
10386120012824RELIINSY30G31251-S.3MLINSY30G31251-S.3ML2023-05-24
10386120012848RELIINSY30G31251-S1MLINSY30G31251-S1ML2023-05-24
10386120012947RELIINSY27G051-S1MLINSY27G051-S1ML2023-05-24

Other Devices Sharing Product Codes

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