FEATHERVAC DISPOSABLE STAPES SEAT - FEATHERVAC DISPOSABLE STAPES SEAT - Grace Medical, Inc.

Duns Number:030849173

Device Description: FEATHERVAC DISPOSABLE STAPES SEAT

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More Product Details

Catalog Number

-

Brand Name

FEATHERVAC DISPOSABLE STAPES SEAT

Version/Model Number

906-002

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

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

LRC

Product Code Name

Instrument, Ent Manual Surgical

Device Record Status

Public Device Record Key

f32e6847-d5e4-499a-b78f-81bf70e36bf6

Public Version Date

January 18, 2021

Public Version Number

2

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

10844505007129

Quantity per Package

5

Contains DI Package

00844505007122

Package Discontinue Date

-

Package Status

In Commercial Distribution

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