MEDLINE INDUSTRIES, INC. - CAP,BOUFFANT,HVYWT SPUNBOND,WHT,24" - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CAP,BOUFFANT,HVYWT SPUNBOND,WHT,24"

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More Product Details

Catalog Number

CRI1203

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

CRI1203

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"

Yes

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

FYF

Product Code Name

CAP, SURGICAL

Device Record Status

Public Device Record Key

a4d12346-0bc4-4e5b-86b5-9679ebcb19c6

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Additional Identifiers

Package DI Number

40884389134918

Quantity per Package

500

Contains DI Package

30884389134911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7