AccessGUDID - DEVICE: Kulzer (J014656077581)

GUDID

Device Identifier (DI) Information

Brand Name: Kulzer
Version or Model: 65607758
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 65607758
Company Name: Kulzer GmbH

Primary DI Number: J014656077581
Issuing Agency: HIBCC
Commercial Distribution End Date: April 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Universal Silicone Adhesive

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?
16658	Dental impression material adhesive	A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHY	TRAY, IMPRESSION, PREFORMED

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
No Device Sizes

Device Record Status

Public Device Record Key: 20f41960-7869-47aa-8040-b9d8f632b0b8
Public Version Date: October 30, 2024
Public Version Number: 3
DI Record Publish Date: April 05, 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: No Unit of Use DI Numbers Found 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: +1(800)431-1785
Email: xx@xx.xx

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