AccessGUDID - DEVICE: Titan™ (10381780247173)

GUDID

Device Identifier (DI) Information

Brand Name: Titan™
Version or Model: RMR-0923-050-502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RMR-0923-050-502
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780247173
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: Titan™ Total Shoulder System Calcar Planer, Trial The Calcar Planer allows for matching of the osteotomy to the body trial.

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:	No
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?
10455	Bone cutter	A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTZ	INSTRUMENT, CUTTING, ORTHOPEDIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 4in L x .775 radius

Device Record Status

Public Device Record Key: cf9f204c-e269-44e7-83e5-61389a18b4b7
Public Version Date: January 25, 2023
Public Version Number: 3
DI Record Publish Date: August 30, 2017