AccessGUDID - DEVICE: Taperloc® Microplasty® (00887868246951)

GUDID

Device Identifier (DI) Information

Brand Name: Taperloc® Microplasty®
Version or Model: 33-103206
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33-103206
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868246951
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
JDL	Prosthesis, hip, semi-constrained (metal cemented acetabular component)
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LZY	Prosthesis, hip, hemi-, femoral, metal ball
KWB	Prosthesis, hip, hemi-, acetabular, cemented, metal
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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: 12.5 mm 110 mm

Device Record Status

Public Device Record Key: b5a64cf5-ad6c-4007-b3f4-e60784e10c98
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: September 14, 2018