AccessGUDID - DEVICE: CEKA & PRECI-LINE ATTACHMENTS (14260576942989)

GUDID

Device Identifier (DI) Information

Brand Name: CEKA & PRECI-LINE ATTACHMENTS
Version or Model: 1325B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1325B
Company Name: Alphadent NV

Primary DI Number: 14260576942989
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 283174985 *Terms of Use

Device Description: PRECI-SAGIX 1.7 HOUSING 20 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:	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?
38580	Sliding dental precision attachment	A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.	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: female housing
Height: 4.4 Millimeter

Device Record Status

Public Device Record Key: 14d25ea7-b326-4786-9684-b9fd6bf6afb7
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: 04260576942982 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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