AccessGUDID - DEVICE: The Better Bunion (G2710228120080)

GUDID

Device Identifier (DI) Information

Brand Name: The Better Bunion
Version or Model: Akin
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mios Marketing, LLC

Primary DI Number: G2710228120080
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2099
Device Count: 1
Labeler D-U-N-S® Number*: 118723037 *Terms of Use

Device Description: Akin Cut Guide, 12mm Staple 18mm x 12mm, 8°

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
63198	Orthopaedic implant aiming/guiding block, single-use	A sterile surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PBF	Orthopaedic Surgical Planning And Instrument Guides

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220717	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
Length: 18 Millimeter
Depth: 12 Millimeter

Device Record Status

Public Device Record Key: 04c26999-fceb-4f11-b0b4-73f345b91ae8
Public Version Date: October 05, 2022
Public Version Number: 1
DI Record Publish Date: September 27, 2022