FDA.reportPublic FDA data

RELI

Primary DI
20386120005502
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
V464-SI
Device description
REDISORB Violet Braided & Coated Polyglycolic Acid, 4-0, MC-2
Published
2015-10-24
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386120005505PackageGS112In Commercial Distribution
20386120005502PackageGS130In Commercial Distribution
00386120005508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612000550510386120005505
2038612000550220386120005502
00386120005508003861200055083861200055080386120005508

GMDN Terms#

Term, Definition table
TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length18Inch

Sterilization Methods#

Method table
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747457Polyglactin 910HEALTHIUM MEDTECH LIMITEDGAM2026-05-25
00810126508331Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508348Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
10817169023019Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00817169023005Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508232Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508249Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508256Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508263Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
03661522100189OPTIME®PETERS SURGICALGAM2026-03-09
03661522100196OPTIME®PETERS SURGICALGAM2026-03-09
03661522100219OPTIME®PETERS SURGICALGAM2026-03-09
03661522100714OPTIME®PETERS SURGICALGAM2026-03-09
03661522100721OPTIME®PETERS SURGICALGAM2026-03-09
03661522100738OPTIME®PETERS SURGICALGAM2026-03-09
03661522100752OPTIME®PETERS SURGICALGAM2026-03-09
03661522100868OPTIME®PETERS SURGICALGAM2026-03-09
03661522100875OPTIME®PETERS SURGICALGAM2026-03-09
03661522101414OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101421OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101438OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101445OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101452OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101469OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101476OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101483OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101490OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101506OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101513OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101575OPTIME®PETERS SURGICALGAM2026-03-09