Welch Allyn, Inc. - GS 777 GS 777 INT D DIAG SYS W 11720 25 - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: GS 777 GS 777 INT D DIAG SYS W 11720 25

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

77794

Brand Name

Welch Allyn, Inc.

Version/Model Number

901027

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

HMF

Product Code Name

Stand, instrument, ac-powered, ophthalmic

Device Record Status

Public Device Record Key

4035324a-3653-45ff-bf3b-83131f332f14

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELCH ALLYN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 374
2 A medical device with a moderate to high risk that requires special controls. 4080
3 A medical device with high risk that requires premarket approval 1