AccessGUDID - DEVICE: American Eagle Instruments (00841013102011)

GUDID

Device Identifier (DI) Information

Brand Name: American Eagle Instruments
Version or Model: AEBH7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEBH7
Company Name: AMERICAN EAGLE INSTRUMENTS, INC.

Primary DI Number: 00841013102011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790776850 *Terms of Use

Device Description: BURNISHER HOLLENBACK 7

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?
64078	Manual dental burnisher, reusable	A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKK	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

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: 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: 1b1481f6-0cb5-4c03-b93b-9c643ac26d3c
Public Version Date: October 05, 2022
Public Version Number: 4
DI Record Publish Date: May 23, 2022