GAP ENDO-EXO MEDULLARY SYSTEM - GAP BONE AWL - Pega Medical Inc

Duns Number:257315713

Device Description: GAP BONE AWL

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More Product Details

Catalog Number

GAP-BAW100

Brand Name

GAP ENDO-EXO MEDULLARY SYSTEM

Version/Model Number

GAP-BAW100

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)

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

HWJ

Product Code Name

AWL

Device Record Status

Public Device Record Key

159d360c-ec06-4f99-a964-9929224671d4

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEGA MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 375
2 A medical device with a moderate to high risk that requires special controls. 825