Catalog Number

-

Brand Name

AMI Custom Crafted FCL 18G x 100mm

Version/Model Number

L-FTN1811G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172602,K172602,K172602,K172602

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

668c820e-da0f-4d34-b7bc-711ca90b922e

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Package DI Number

28809407788438

Quantity per Package

10

Contains DI Package

18809407788431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX