FDA.reportPublic FDA data

Pure Buff

Primary DI
00859611006204
Brand
Pure Buff
Company
JORDCO INC
Model
PBM-S
Catalog number
PBM-S
Device description
Pure Buff Mandrels
Published
2020-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EHJDisk, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859611006204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859611006204008596110062048596110062040859611006204

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory mandrelA round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
803063981
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859611006112EndoringERUL-sERUL-S2020-08-08
00859611006129EndoringERULX-SERULX-S2020-08-08
00859611006259EndoringERR-SERR-S2020-08-08
00859611006266EndoringERRFR-SERRFR-S2020-08-08
00859611006273EndoringERRFL-SERRFL-S2020-08-08
00859611006570EndoringERRFRRG-SERRFRRG-S2020-08-08
00859611006587EndoringERRFLRG-SERRFLRG-S2020-08-08
00859611006631EndoringERULRG-SERULRG-S2020-08-08
00859611006648EndoringERULXRG-SERULXRG-S2020-08-08
00859611006709EndoringER2SP-EX-SER2SP-EX-S2020-08-08
00859611006723EndoringER2-EX-SER2-EX-S2020-09-07
00859611006730EnodringER-EX-SER-EX-S2020-09-07
00859611006716EndogelEG-BPEG-BP2020-08-10
00859611006006EndogelEG-sEG-S2020-08-08
00859611006020EndoringER2-SER2-S2020-08-08
00859611006037EndoringER2V-SER2V-S2020-08-08
00859611006044EndoringER2Y-SER2Y-S2020-08-08
00859611006051EndoringER2G-SER2G-S2020-08-08
00859611006068EndoringER2VX-SER2VX-S2020-08-08
00859611006075EndoringER2BX-VER2BX-S2020-08-08

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