Welch Allyn, Inc. - PHYSICIAN S STAND-ON SCALE 18x14x1 1 4 - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: PHYSICIAN S STAND-ON SCALE 18x14x1 1 4

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More Product Details

Catalog Number

5102

Brand Name

Welch Allyn, Inc.

Version/Model Number

901110

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

FRI

Product Code Name

SCALE, STAND-ON, PATIENT

Device Record Status

Public Device Record Key

5f92598c-2fe9-4ef3-8841-7df8fe9ea6f7

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

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