FDA.reportPublic FDA data

RELI

Primary DI
00386120006000
Brand
RELI
Company
MYCO MEDICAL SUPPLIES INC.
Model
N1668-SI
Device description
REDILON Monofilament Polyamide (Nylon), Black, 5-0, MPS-3
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386120006007PackageGS112In Commercial Distribution
20386120006004PackageGS130In Commercial Distribution
00386120006000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612000600710386120006007
2038612000600420386120006004
00386120006000003861200060003861200060000386120006000

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

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

Regulatory Flags#

DUNS number
879187821
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386120005669RELIPT7773-SI2015-10-24
00386120006314RELIPT1001-SI2016-04-15
00386120006321RELIPT1002-SI2016-04-15
00386120007854RELIPT556-PPT556-P2017-10-18
00386120008196RELI®PT556-MPT556-M2019-05-13
00386120009735RELI®PT1001-MPT1001-M2019-05-13
00386120009742RELI®PT1002-MPT1002-M2019-05-13
00386120009773RELI®PT7773-MPT7773-M2019-05-13
00386120014227RELI®SBCS21G-122026-02-02
00386120014234RELI®SBCS23G-122026-02-02
00386120014241RELI®SBCS25G-122026-02-02
10386120014224RELI®SBCS21G-122026-02-02
10386120014231RELI®SBCS23G-122026-02-02
10386120014248RELI®SBCS25G-122026-02-02
00386120014128RELISBCN-R20G1012025-11-21
00386120014135RELISBCN-R20G1142025-11-21
00386120014142RELISBCN-R20G1512025-11-21
00386120014159RELISBCN-R21G1012025-11-21
00386120014166RELISBCN-R21G1142025-11-21
00386120014173RELISBCN-R21G1512025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015284SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015437SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015482SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015741SUTUMEDUnilene S.A.C.GAR2023-01-06