Catalog Number

72205127

Brand Name

MINITAPE

Version/Model Number

72205127

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K132357,K132357

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

fe9424a5-0641-4231-95fc-18f68c7d2f64

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 29, 2019

Package DI Number

20885556727724

Quantity per Package

6

Contains DI Package

00885556727720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX