FDA.report

Golnit PTFE Sutures

Primary DI
00860293000602
Brand
Golnit PTFE Sutures
Company
Golnit Sutures
Model
mRD401648-45
Device description
PTFE Non-absorbable Suture 18 inch in length, USP 4/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile
Published
2018-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications

CodeDeviceSpecialtyClass
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860293000602PrimaryGS10
00860000584067Unit of UseGS10

GMDN Terms

TermDefinition
Polytetrafluoroethylene sutureA sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) intended to join (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, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.

Device Sizes

TypeValueUnit
Length18Inch

Sterilization Methods

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 DIBrandModelCatalogPublished
10860293000685Golnit PTFE SuturemTH601333-452018-10-09
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
00860293000695Golnit PTFE SuturemTH501333-452018-10-09
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

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