TAPESTRY RC Biointegrative Implant System - Disposable kit - Embody, Inc.

Duns Number:079544913

Device Description: Disposable kit

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More Product Details

Catalog Number

TR-3030-A6

Brand Name

TAPESTRY RC Biointegrative Implant System

Version/Model Number

TR-3030-A6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

d6bb6b2d-69e7-4234-aa3a-a4fa49485e1f

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EMBODY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 14