AccessGUDID - DEVICE: CEKA & PRECI-LINE ATTACHMENTS (04260576940100)

GUDID

Device Identifier (DI) Information

Brand Name: CEKA & PRECI-LINE ATTACHMENTS
Version or Model: 1102/H/MR/IN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1102/H/MR/IN
Company Name: Alphadent NV

Primary DI Number: 04260576940100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283174985 *Terms of Use

Device Description: Stainless Steel Mini Rider

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
38577	Bar dental precision attachment	A small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	ATTACHMENT, PRECISION, ALL

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
Device Size Text, specify: rider
Height: 2.8 Millimeter

Device Record Status

Public Device Record Key: 7feec301-8b32-4ac3-bd29-82ea0ec10a60
Public Version Date: April 07, 2021
Public Version Number: 1
DI Record Publish Date: March 30, 2021