Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 80-08119-S

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

-

Product Code

HMT

Product Code Name

Drape, patient, ophthalmic

Public Device Record Key

33e2be38-2e43-48c5-b5ff-df905579cab8

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

February 02, 2021

Package DI Number

26931918196760

Quantity per Package

17

Contains DI Package

16931918196763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton