AccessGUDID - DEVICE: PREPSTART (00816594021785)

GUDID

Device Identifier (DI) Information

Brand Name: PREPSTART
Version or Model: 200259-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200259-00
Company Name: DANVILLE MATERIALS, LLC

Primary DI Number: 00816594021785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 601302743 *Terms of Use

Device Description: PREPSTART

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?
45404	Dental abrasive air jet system control unit	A device that is a component of a dental abrasive air jet system and that is used to control and regulate the supply of air and water that is fed through the dedicated handpiece together with an abrasive powder giving a concise jet that impacts the surface of the teeth being treated. The dentist will typically regulate the air/water supply through controls on the front panel whilst a foot-switch controls the abrasion process. Pressurized air from a standard air compressor and temperate water are connected to this device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOJ	AIRBRUSH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 2a17cca9-ce03-46e4-a844-6883278832eb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 22, 2016

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(760)743-7744 ext: 145
Email: xxx@xxx.xxx

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