AccessGUDID - DEVICE: Luxator-Bein (08961104675889)

GUDID

Device Identifier (DI) Information

Brand Name: Luxator-Bein
Version or Model: Inverted Curved, 3.0 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 325-386E9
Company Name: MELPEX BEAUTY INSTRUMENTS

Primary DI Number: 08961104675889
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645674404 *Terms of Use

Device Description: Reusable Luxator-Bein, Inverted Curved, 3.0 mm, 160 mm Length, non-sterile

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":	Yes
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?
16480	Dental elevator, tooth/root	A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMJ	Elevator, Surgical, Dental

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
Length: 160 Millimeter
Length: 6.29 Inch
Device Size Text, specify: Tip Width 3.0 mm

Device Record Status

Public Device Record Key: 1bc5cef7-ff32-4e8f-947a-d2aca9c3787f
Public Version Date: May 06, 2026
Public Version Number: 1
DI Record Publish Date: April 28, 2026