Fenestrated Surgical Drape - DRAPE SURGICAL MISTY 18X18 - 2PLY T-180 W/FEN - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: DRAPE SURGICAL MISTY 18X18 - 2PLY T-180 W/FEN (S/R 17103)

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More Product Details

Catalog Number

96301312

Brand Name

Fenestrated Surgical Drape

Version/Model Number

96301312

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Device Record Status

Public Device Record Key

e9991ea4-c8a0-4f52-9ad6-f1867ab9ba2b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDARD TEXTILE CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 9