Zip 24 Surgical Skin Closure Device - Zip 24 Surgical Skin Closure Device, BSC - ZIPLINE MEDICAL, INC.

Duns Number:962534124

Device Description: Zip 24 Surgical Skin Closure Device, BSC

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More Product Details

Catalog Number

7616

Brand Name

Zip 24 Surgical Skin Closure Device

Version/Model Number

667616001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2019

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)

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

6239613f-3a90-4940-a739-45b89f29a391

Public Version Date

February 01, 2021

Public Version Number

5

DI Record Publish Date

March 16, 2017

Additional Identifiers

Package DI Number

10853114007031

Quantity per Package

5

Contains DI Package

00853114007034

Package Discontinue Date

March 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Zip 24, 5-pack, BSC

"ZIPLINE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11