AccessGUDID - DEVICE: American Eagle Instruments (00841013107634)

GUDID

Device Identifier (DI) Information

Brand Name: American Eagle Instruments
Version or Model: AEGDP11TTQT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEGDP11TTQT
Company Name: AMERICAN EAGLE INSTRUMENTS, INC.

Primary DI Number: 00841013107634
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790776850 *Terms of Use

Device Description: GRACEY DP 11 TALON TOUGH QUIK TIP

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):	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?
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMS	CURETTE, PERIODONTIC

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e8dda22-fa77-4dd0-99cf-6f1790cd1caf
Public Version Date: August 10, 2023
Public Version Number: 4
DI Record Publish Date: July 24, 2022