FDA.reportPublic FDA data

Golnit Nylon Monofilament Suture

Primary DI
00850043243021
Brand
Golnit Nylon Monofilament Suture
Company
Golnit Sutures
Model
NB2D4018-75
Device description
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 4/0, Reverse Cutting Needle, 18mm, 3/8 curvature, Sterile
Published
2022-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00850043243021PrimaryGS10
00850043243052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043243021008500432430218500432430210850043243021
00850043243052008500432430528500432430520850043243052

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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 to withstand normal stress. 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
Device Size Text, specify0
Length30Inch

Regulatory Flags#

DUNS number
079932697
Device count
12
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000584081Golnit PTFE SutureFTD501324d-752022-09-17
10860293000685Golnit PTFE SuturemTH601333-452018-10-09
00860293000695Golnit PTFE SuturemTH501333-452018-10-09
00850043243007Golnit Nylon Monofilament SutureNB2D5016-752022-09-17
00850043243014Golnit Nylon Monofilament SutureNB2D4016-752022-09-17
00850043243038Golnit Nylon Monofilament SutureNB2D3019-752022-09-17
00850043243083Golnit Nylon Monofilament SutureNB2D6016-752022-09-17
00850043243090Golnit Nylon Monofilament SutureNB2D5018-752022-09-17
00850043243076Golnit Nylon Monofilament SutureNB2D5016-752022-09-17
00850043243069Golnit Nylon Monofilament SutureNB2D4016-752022-09-17
00850043243052Golnit Nylon Monofilament SutureNB2D4018-752022-09-17
00850043243045Golnit Nylon Monofilament SutureNB2D3019-752022-09-17
00850043243113Golnit Nylon Monofilament SutureNB2D6016-752022-09-17
00850043243106Golnit Nylon Monofilament SutureNB2D5018-752022-09-17
00860000584098Golnit PTFE SutureFTD501324d-752022-09-17
00860293000602Golnit PTFE SuturesmRD401648-452018-03-08
00860293000619Golnit PTFE SuturemRD501343-452018-03-08
00860293000626Golnit PTFE SuturesmRD301956-452018-03-08
00860293000633Golnit PTFE SuturemRD501643-452018-03-08
00860293000640Golnit PTFE SuturemTH401343-452018-03-08

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
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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
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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