FDA.report

J & J INSTRUMENTS

Primary DI
00817524024975
Brand
J & J INSTRUMENTS
Company
J & J INSTRUMENTS INC
Model
13-270
Device description
WAX SPATULA #7
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIKCarver, Wax, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524024975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524024975008175240249758175240249750817524024975

GMDN Terms

TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
783328149
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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