AccessGUDID - DEVICE: INSTRUMENT (07613327195521)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 1235-0-846M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1235-0-846M
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327195521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: ADM MONOPOLAR TRIAL INSERT 28/46- NOT COMPATIBLE WITH MDM

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?
58479	Femoral head prosthesis trial	A copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. 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, calicum-phosphate
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
HWC	Screw, fixation, bone
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWL	Prosthesis, hip, hemi-, femoral, metal
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

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: 6471ed38-8683-4ea5-9a17-8f8f90df864d
Public Version Date: February 21, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2016