AccessGUDID - DEVICE: Cleft Palate Kit (B562CPKIT0)

GUDID

Device Identifier (DI) Information

Brand Name: Cleft Palate Kit
Version or Model: CP-KIT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Wishbone Medical, Inc.

Primary DI Number: B562CPKIT0
Issuing Agency: HIBCC
Commercial Distribution End Date: August 23, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 062355158 *Terms of Use

Device Description: Cleft Palate Kit

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:	Yes
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?
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, Surgical Instrument, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 6c21b076-1aec-4ea9-851b-a95623b6e3fa
Public Version Date: June 20, 2025
Public Version Number: 3
DI Record Publish Date: September 07, 2021