FDA.reportPublic FDA data

Golnit Nylon Monofilament Suture

Primary DI
00850043243076
Brand
Golnit Nylon Monofilament Suture
Company
Golnit Sutures
Model
NB2D5016-75
Device description
Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 5/0, Reverse Cutting Needle, 16mm, 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
00850043243007PrimaryGS10
00850043243076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043243007008500432430078500432430070850043243007
00850043243076008500432430768500432430760850043243076

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
10860293000685Golnit PTFE SuturemTH601333-452018-10-09
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
00860293000695Golnit PTFE SuturemTH501333-452018-10-09
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
00860293000657Golnit PTFE SuturesmRD401853-452018-03-08
00860293000664Golnit PTFE SuturemRD601338-452018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14946585362283CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362290CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362306CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362313CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362320CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362337CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362344CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362351CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362368CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362375CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362382CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362399CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362405CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
14946585362412CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-12
03661522103128CARDIONYL®PETERS SURGICALGAR2026-03-05
03661522103135CARDIONYL®PETERS SURGICALGAR2026-03-05
14946585347785CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348416CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348423CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348430CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585348492CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585355292CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
04946585357374CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585357487CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-03-03
14946585358002CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-02-10
14946585042222CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2026-01-26
14946585037143CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
04946585037153CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585041935CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13
14946585042208CROWNJUN Nylon SutureKONO SEISAKUSHO CO.,LTD.GAR2025-11-13