FDA.report

Jiffy Proximal Saw

Primary DI
00883205015877
Brand
Jiffy Proximal Saw
Company
ULTRADENT PRODUCTS, INC.
Model
1166
Catalog number
1166
Device description
Jiffy Proximal Saw
Published
2018-02-07
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
EHMSTRIP, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00883205015877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205015877008832050158778832050158770883205015877

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
true
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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