AccessGUDID - DEVICE: CEKA & PRECI-LINE ATTACHMENTS (14260576941821)

GUDID

Device Identifier (DI) Information

Brand Name: CEKA & PRECI-LINE ATTACHMENTS
Version or Model: H 16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H 16
Company Name: Alphadent NV

Primary DI Number: 14260576941821
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 283174985 *Terms of Use

Device Description: M3 SOLDERING ACC. EXTRACORONAL 2 PCS

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:	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?
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.	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
Outer Diameter: 3 Millimeter
Device Size Text, specify: M3 threading

Device Record Status

Public Device Record Key: b0d5e7ff-c6a3-48e7-8b08-1c3244cb4c0e
Public Version Date: April 07, 2021
Public Version Number: 1
DI Record Publish Date: March 30, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04260576941824 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +328004969500
Email: info@ckpl.eu

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