Cartilage MACROTOME Tissue Support - Cartilage MACROTOME Tissue Support, For Use With - Grace Medical, Inc.

Duns Number:030849173

Device Description: Cartilage MACROTOME Tissue Support, For Use With Cartilage MACROTOME, Stainless Steel

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More Product Details

Catalog Number

-

Brand Name

Cartilage MACROTOME Tissue Support

Version/Model Number

990-106

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

FZT

Product Code Name

Cutter, Surgical

Device Record Status

Public Device Record Key

9df7ae15-fca6-49f6-842c-111b34ba4ef9

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRACE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 200
2 A medical device with a moderate to high risk that requires special controls. 564