AccessGUDID - DEVICE: ACE (00614950021277)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 04974101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04974101
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950021277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: ONE PIECE CONNECTION TO THE CONTRA ANGLE FOR 3HD 27TL

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?
63511	Dental power tool converter attachment, rotary	A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a rotational mechanical motion to achieve a specific function [e.g., drilling] during dental or orthodontic procedures. It is not an endpiece; an appropriate interchangeable endpiece (e.g., drill bit, dental bur) is intended to be fixed to the working end of this device. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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
Length: 27 Millimeter

Device Record Status

Public Device Record Key: f04bdedd-618a-4f2a-a259-2c4e042ec8cf
Public Version Date: October 28, 2019
Public Version Number: 1
DI Record Publish Date: October 19, 2019