Punch - Hair Transplant And Acne Scar Punch - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Hair Transplant And Acne Scar Punch

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More Product Details

Catalog Number

-

Brand Name

Punch

Version/Model Number

199-179-1.0

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

-

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

LRY

Product Code Name

PUNCH, SURGICAL

Device Record Status

Public Device Record Key

c66bab65-182f-4657-add9-a1170d76b302

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414