Catalog Number

SPT-DRAPXLSCS

Brand Name

Medline Industries, Inc.

Version/Model Number

SPT-DRAPXLSCS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HMT

Product Code Name

Drape, patient, ophthalmic

Public Device Record Key

1741b866-2909-4cad-97f1-b876dd16dae6

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

November 07, 2016

Package DI Number

40080196498810

Quantity per Package

50

Contains DI Package

10080196498819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE