AccessGUDID - DEVICE: ACE (00614950011803)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 04948002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04948002
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950011803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: BUR TREPHINE 35TL 2.75ID 3.5OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION

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:	No
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?
46621	Titanium dental bur	A rotary cutting device, the working end of which is made from titanium (Ti), and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It can also be used to cut metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWK	TREPHINE

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: 4820a4a7-6fe2-492e-8865-3ab1ded93631
Public Version Date: March 23, 2020
Public Version Number: 2
DI Record Publish Date: October 12, 2019