ASP MEDICAL - GOWN, PATIENT EXAM, BLUE, M/L, REVERSIBLE WITH - Asp Global, LLC

Duns Number:080361159

Device Description: GOWN, PATIENT EXAM, BLUE, M/L, REVERSIBLE WITH FRONT/BACK OPENING, NECK AND WAIST TIES, 50 GOWN, PATIENT EXAM, BLUE, M/L, REVERSIBLE WITH FRONT/BACK OPENING, NECK AND WAIST TIES, 50EA/CS

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More Product Details

Catalog Number

-

Brand Name

ASP MEDICAL

Version/Model Number

GEA042

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)

Yes

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 Details

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Device Record Status

Public Device Record Key

1cf6f4b1-4a6a-4826-8df1-19bbae0fc8fe

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASP GLOBAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1046
2 A medical device with a moderate to high risk that requires special controls. 23
U Unclassified 2