AccessGUDID - DEVICE: CAPTURE™ High Torque Screw System (10381780123064)

GUDID

Device Identifier (DI) Information

Brand Name: CAPTURE™ High Torque Screw System
Version or Model: CSS500000670WT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSS500000670WT
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780123064
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The washer is used in conjunction with the Capture High Torque Screw System.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092440	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: .50 in outer dia x .318 in inner dia x .0394 in H

Device Record Status

Public Device Record Key: 597904e5-0624-402c-b60c-19bb6f5b5df6
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017