AccessGUDID - DEVICE: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET (00810933031633)

GUDID

Device Identifier (DI) Information

Brand Name: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET
Version or Model: 1080-695
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1080-695
Company Name: Conformis, Inc.

Primary DI Number: 00810933031633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: ACTERA HIP TRIAL NECK, REUSABLE SIZE 10-11-12 HIGH OFFSET

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?
58481	Femoral stem prosthesis trial	A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231178	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
No Device Sizes

Device Record Status

Public Device Record Key: 559799c5-5836-48c8-bbd6-fd7bfe489d0f
Public Version Date: July 13, 2023
Public Version Number: 1
DI Record Publish Date: July 05, 2023