FDA.reportPublic FDA data

Golnit Nylon Monofilament Suture

Primary DI
00850043243045
Brand
Golnit Nylon Monofilament Suture
Company
Golnit Sutures
Model
NB2D3019-75
Device description
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 3/0, Reverse Cutting Needle, 19mm, 3/8 curvature, Sterile
Published
2022-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
00850043243038PrimaryGS10
00850043243045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043243038008500432430388500432430380850043243038
00850043243045008500432430458500432430450850043243045

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079932697
Device count
12
DM exempt
false
Premarket exempt
true
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
00850043243571Golnit PTFE SuturemRD501848-452026-06-08
00850043243618Golnit PTFE SuturemRD401343-452026-06-08
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
00850043243021Golnit Nylon Monofilament SutureNB2D4018-752022-09-17
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052516SharpointSurgical Specialties México, S. de R.L. de C.V.GAR2026-08-26
10705031089020ETHILONETHICON, LLCGAR2026-08-25
10705031096479ETHILONETHICON, LLCGAR2026-08-25
00816848022964SUPRAMIDS JACKSON INCGAR2026-08-21
00816848022988SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023008SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023329SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023343SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023367SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023381SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023527SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023541SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023664SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023688SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023787SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023800SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023824SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023848SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023862SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023886SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023947SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023954SUPRAMIDS JACKSON INCGAR2026-08-21
00816848024029SUPRAMIDS JACKSON INCGAR2026-08-21
08903837402325TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
08903837799326TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
10705031245587ETHILONETHICON, LLCGAR2026-08-17
10705031245624ETHILONETHICON, LLCGAR2026-08-17
10705031465374ETHILONETHICON, LLCGAR2026-08-17
10705031465381ETHILONETHICON, LLCGAR2026-08-17
10705031465404ETHILONETHICON, LLCGAR2026-08-17