AccessGUDID - DEVICE: Arcos® Modular Revision System (00887868477812)

GUDID

Device Identifier (DI) Information

Brand Name: Arcos® Modular Revision System
Version or Model: 31-301837
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-301837
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868477812
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?
35297	Medullary canal orthopaedic reamer, flexible	An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090757	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: 25 mm

Device Record Status

Public Device Record Key: ae85a26d-8b8c-4ea3-9a5f-ef7aa330a2d7
Public Version Date: May 30, 2025
Public Version Number: 2
DI Record Publish Date: April 02, 2022