FDA.reportPublic FDA data

Premium UNIFY Gut Sutures

Primary DI
10814639021407
Brand
Premium UNIFY Gut Sutures
Company
APPLIED DENTAL, INC.
Model
PMJ-418R19
Device description
Premium UNIFY Gut Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 18"
Published
2015-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10814639021407PackageGS112In Commercial Distribution
20814639021404PackageGS1100In Commercial Distribution
00814639021400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902140710814639021407
2081463902140420814639021404
00814639021400008146390214008146390214000814639021400

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@AD-Surgical.com

Regulatory Flags#

DUNS number
017524666
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
true
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
10814639026747Premium UNIFY Silk SuturesPMS-318R192025-06-20
10814639026754Premium UNIFY Silk SuturesPMS-418R192025-06-20
10814639026761Premium UNIFY Silk SuturesPMS-518R192025-06-20
10814639026778Premium UNIFY Silk SuturesPSS-418R132025-06-20
10814639026785Premium UNIFY Silk SuturesPSS-518R132025-06-20
10814639026792Premium UNIFY Silk SuturesPSS-618R132025-06-20
10814639026563UNIFY Chromic Gut Surgical SuturesM-C318R192025-06-19
10814639026587UNIFY Chromic Gut Surgical SuturesM-C418R162025-06-19
10814639026594UNIFY Chromic Gut Surgical SuturesM-C518R162025-06-19
10814639026600UNIFY Chromic Gut Surgical SuturesS-C618R132025-06-19
10814639026617UNIFY Plain Gut SuturesS-J618R132025-06-19
10814639026624UNIFY Plain Gut Surgical SuturesL-J230R24L-J230R242025-06-19
10814639026648UNIFY Plain Gut SuturesM-J318R192025-06-19
10814639026655UNIFY Plain Gut SuturesM-J418R162025-06-19
10814639026662UNIFY Plain Gut SuturesM-J430R19M-J430R192025-06-19
10814639026679UNIFY Plain Gut SuturesM-J518R162025-06-19
10814639026686UNIFY Chromic Surgical Sutures M-C518R19 2025-06-19
10814639026693UNIFY Plain Gut SuturesM-J518R192025-06-19
10814639026730UNIFY Polyester Surgical SuturesL-E230R262025-06-19
10814639026808UNIFY Polyester Surgical SuturesS-E418R132025-06-19

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