AccessGUDID - DEVICE: Arcos® Modular Revision System (00887868476204)

GUDID

Device Identifier (DI) Information

Brand Name: Arcos® Modular Revision System
Version or Model: 31-301102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-301102
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868476204
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?
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100469	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
Device Size Text, specify: 60 mm Size B

Device Record Status

Public Device Record Key: d4eea87a-c70a-4b67-bf8a-ac69df89124c
Public Version Date: May 30, 2025
Public Version Number: 2
DI Record Publish Date: June 22, 2022