AccessGUDID - DEVICE: Equinoxe (10885862268129)

GUDID

Device Identifier (DI) Information

Brand Name: Equinoxe
Version or Model: 308-10-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 308-10-05
Company Name: Exactech, Inc.

Primary DI Number: 10885862268129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157565946 *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?
61006	Humeral stem extension prosthesis	A sterile implantable component of a total shoulder prosthesis intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus (e.g., due to trauma or tumour) to achieve the additional length required for connection to a humeral body. It is a modular arrangement of interlocking parts so the length can be configured intraoperatively. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143659	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
Length: 0 Millimeter
Device Size Text, specify: Size Large

Device Record Status

Public Device Record Key: 690d7f2d-638b-49d3-bdcc-cbb7bf3d4adf
Public Version Date: February 01, 2022
Public Version Number: 4
DI Record Publish Date: November 16, 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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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