AccessGUDID - DEVICE: Spiral drill reverse action Re-Set (E219J503608201)

GUDID

Device Identifier (DI) Information

Brand Name: Spiral drill reverse action Re-Set
Version or Model: J5036.0820
Commercial Distribution Status: In Commercial Distribution
Catalog Number: J5036.0820
Company Name: ALTATEC GmbH

Primary DI Number: E219J503608201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 322018193 *Terms of Use

Device Description: Spiral drill reverse action for CAMLOG® and CONELOG® Re-Set, Ø 0.82 mm,

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):	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?
45319	Dental implant extractor	A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJL	Bur, 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: Yes
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: c1533e5c-1fa0-492b-a55f-09e2e2a0a1ea
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023