FDA.report

RELI

Primary DI
20386120005366
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
GC634-BRC
Device description
REDIGUT Chromic Gut Suture 5-0, MFS-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

Related Records

Product Codes

CodeName
GALSuture, Absorbable, Natural

Product Code Classifications

CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10386120005369PackageGS112In Commercial Distribution
20386120005366PackageGS130In Commercial Distribution
00386120005362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612000536910386120005369
2038612000536620386120005366
00386120005362003861200053623861200053620386120005362

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
Length27Inch

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
false
Sterilization required before use
false

Other Devices From This Company

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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

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