AccessGUDID - DEVICE: MISHA® Knee System, Small, Left (00856047005795)

GUDID

Device Identifier (DI) Information

Brand Name: MISHA® Knee System, Small, Left
Version or Model: 2-1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Moximed, Inc.

Primary DI Number: 00856047005795
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808178383 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60373	Implantable knee unloader	A sterile, implantable metallic device intended to reduce the load on the medial compartment of the knee for the treatment of degenerative articular cartilage (e.g., osteoarthritis) without any other alteration to the joint (i.e., no other arthroplasty or prosthesis implant). It typically consists of bases fixed to the medial side of the femoral and tibial condyles, which hold in place a spring-like absorber designed to absorb, redistribute or shift loads on the medial knee compartment. The implant is subcutaneous and extracapsular, and is typically introduced through small skin incisions. It is typically supplied with the required screws and surgical instruments necessary for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QVV	Medial Knee Implanted Shock Absorber

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220033	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
No Device Sizes

Device Record Status

Public Device Record Key: 28f426e5-dd01-4bd1-8bc0-fbfce99c8a58
Public Version Date: April 28, 2025
Public Version Number: 3
DI Record Publish Date: May 05, 2023

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

[?]

No Customer Contact currently defined

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