AccessGUDID - DEVICE: Safescraper Twist curve Volumizer (08056585230020)

GUDID

Device Identifier (DI) Information

Brand Name: Safescraper Twist curve Volumizer
Version or Model: 5501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5501
Company Name: META TECHNOLOGIES SRL

Primary DI Number: 08056585230020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 442368394 *Terms of Use

Device Description: SAFESCRAPER TWIST curve VOLUMIZER is a medical device intended for harvesting, collecting and releasing of autologous bone in regenerative applications in oral surgery.

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):	No
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?
63815	Bone collection scraper	A sterile, surgical device intended for the manual removal, through scraping, and collection of autogenous bone particles from a patient, typically as part of a dental surgical procedure. It consists of a handle with a scraping blade and a collection chamber. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXP	Bone Particle Collector

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: 419315d6-4361-4d6a-a8da-0eb3406c198c
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024