Retract-o-Tape 10g x 45.8cm Thin Wall - QUEST MEDICAL INC

Duns Number:041810693

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More Product Details

Catalog Number

-

Brand Name

Retract-o-Tape 10g x 45.8cm Thin Wall

Version/Model Number

1015

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

Yes

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

GAE

Product Code Name

Snare, Surgical

Device Record Status

Public Device Record Key

7439e9a7-e3a8-4526-b466-147e305b3d2e

Public Version Date

November 13, 2019

Public Version Number

2

DI Record Publish Date

October 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUEST MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 168
U Unclassified 8