AccessGUDID - DEVICE: Dispensing Gun 10:1 (J014660360830)

GUDID

Device Identifier (DI) Information

Brand Name: Dispensing Gun 10:1
Version or Model: 66036083
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66036083
Company Name: Kulzer GmbH

Primary DI Number: J014660360830
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Instruments, Dental Hand

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?
62514	Syringe dispensing gun, reusable	A hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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: 99c219e5-4140-48e5-9cab-1a13cef1ec28
Public Version Date: October 30, 2024
Public Version Number: 2
DI Record Publish Date: September 09, 2024

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: No
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: customerservice.na@kulzer-dental.com

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