DB TITANIUM STRUT - DB TITANIUM STRUT 1.50 - 2.00 MM L - Grace Medical, Inc.

Duns Number:030849173

Device Description: DB TITANIUM STRUT 1.50 - 2.00 MM L TITANIUM/SILICONE

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More Product Details

Catalog Number

-

Brand Name

DB TITANIUM STRUT

Version/Model Number

657B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K061853

Product Code Details

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Device Record Status

Public Device Record Key

fe69fb33-713e-47d8-92ad-0cff8e57ae1a

Public Version Date

January 11, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2019

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