WEGO-Nylon Non-absorbable Surgical Suture With Needle - Foosin Medical Supplies Inc., Ltd.

Duns Number:528180159

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More Product Details

Catalog Number

-

Brand Name

WEGO-Nylon Non-absorbable Surgical Suture With Needle

Version/Model Number

G1006005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080684,K080684

Product Code Details

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Device Record Status

Public Device Record Key

e4c10efa-ac7a-447f-a362-b6d99c79d327

Public Version Date

September 09, 2021

Public Version Number

6

DI Record Publish Date

November 30, 2015

Additional Identifiers

Package DI Number

06941813690054

Quantity per Package

12

Contains DI Package

06941813600053

Package Discontinue Date

September 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"FOOSIN MEDICAL SUPPLIES INC., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2142