AccessGUDID - DEVICE: MAESTRO TOTAL WRIST (00880304481091)

GUDID

Device Identifier (DI) Information

Brand Name: MAESTRO TOTAL WRIST
Version or Model: 180365
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 180365
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304481091
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:	Yes
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?
35663	Total wrist carpal articulation prosthesis	An implantable device designed to replace some of the carpal bone articulating surfaces as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is implanted into hand bone distally; it may interface with a spacer. Fixation devices for implantation (e.g., screws) may be included with the prosthesis and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWN	PROSTHESIS, WRIST, CARPAL LUNATE
KWO	PROSTHESIS, WRIST, CARPAL SCAPHOID
JWJ	PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042032	000
K050028	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: +4MM HEIGHT

Device Record Status

Public Device Record Key: a9f0a5c0-63f6-4c19-89f2-77667c7d7dda
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)348-9500
Email: customerservice@zimmerbiomet.com

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