Catalog Number

RS1000

Brand Name

Tesslagra

Version/Model Number

RS1000

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101688,K101688

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

d7c563f8-7df2-45b1-bcc7-3e845e54458a

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

00850024023383

Quantity per Package

20

Contains DI Package

00850024023376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE