FDA.report

PREPSTART

Primary DI
00816594021785
Brand
PREPSTART
Company
DANVILLE MATERIALS, LLC
Model
200259-00
Catalog number
200259-00
Device description
PREPSTART
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KOJAIRBRUSH

Product Code Classifications

CodeDeviceSpecialtyClass
KOJAirbrushDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816594021785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594021785008165940217858165940217850816594021785

GMDN Terms

TermDefinition
Dental abrasive air jet system control unitA 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)743-7744xxx@xxx.xxx

Regulatory Flags

DUNS number
601302743
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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