AccessGUDID - DEVICE: CERALOG® PL Implant removal driver, L 23.0 mm (07640161397170)

GUDID

Device Identifier (DI) Information

Brand Name: CERALOG® PL Implant removal driver, L 23.0 mm
Version or Model: HP5330.0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HP5330.0002
Company Name: CeramTec Schweiz GmbH

Primary DI Number: 07640161397170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483229493 *Terms of Use

Device Description: No description.

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):	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?
64627	Dental implant holding endpiece, reusable	A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, Contra- And Right-Angle Attachment, 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
Special Storage Condition, Specify: Keep dry, Keep out of sunlight
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f803680-0a37-4be2-ae1d-a0d52dc6da4c
Public Version Date: February 25, 2025
Public Version Number: 4
DI Record Publish Date: April 29, 2024