AccessGUDID - DEVICE: American Eagle Instruments (00841013100284)

GUDID

Device Identifier (DI) Information

Brand Name: American Eagle Instruments
Version or Model: AEEXP9Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AEEXP9Z
Company Name: AMERICAN EAGLE INSTRUMENTS, INC.

Primary DI Number: 00841013100284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790776850 *Terms of Use

Device Description: EXPLORER SE 9 (3/8) STAINLESS

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?
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIX	PROBE, 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: 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: edb7190b-d99c-4d01-8b06-4376ffe13f58
Public Version Date: January 20, 2023
Public Version Number: 5
DI Record Publish Date: May 23, 2022