MediChoice - Punch Biopsy Dermal Stainless Steel Polystyrene 8 - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Punch Biopsy Dermal Stainless Steel Polystyrene 8 Millimeter Sterile Not Made With Natural Punch Biopsy Dermal Stainless Steel Polystyrene 8 Millimeter Sterile Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

DP0800

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

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

LRY

Product Code Name

PUNCH, SURGICAL

Device Record Status

Public Device Record Key

f773934c-8e76-4bee-b92b-e37d92bc6135

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Additional Identifiers

Package DI Number

30885632109717

Quantity per Package

25

Contains DI Package

10885632109713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1