AccessGUDID - DEVICE: INSTRUMENT (07613327194371)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 1235-0-858
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1235-0-858
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327194371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: RESTORATION ADM/MDM TRIAL INSERT 28/58/52H

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?
58480	Acetabulum prosthesis trial, prefabricated, reusable	A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWL	Prosthesis, hip, hemi-, femoral, metal
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
HWC	Screw, fixation, bone

FDA Premarket Submission

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

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: 16b47c93-8935-436c-a0eb-4cc67a414cbb
Public Version Date: September 30, 2022
Public Version Number: 8
DI Record Publish Date: September 24, 2016