CAPTURE™ - CAPTURE™ High Torque Screw SystemThe tissue - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: CAPTURE™ High Torque Screw SystemThe tissue protector is used during guide pin placement i CAPTURE™ High Torque Screw SystemThe tissue protector is used during guide pin placement in the Capture high torque screw system.

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More Product Details

Catalog Number

PR5000506070

Brand Name

CAPTURE™

Version/Model Number

TPR-5000-506-070

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

c7d2b4a6-2e19-40b6-b8e4-7d72ceb3a286

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

August 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15