FDA.report

J&J Instruments

Primary DI
00817524022841
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
06-850
Device description
WEDGE SHAPED MILLIMETER GAUGE
Published
2019-10-07
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
EILGauge, Depth, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524022841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524022841008175240228418175240228410817524022841

GMDN Terms

TermDefinition
Interproximal dental gauge, reusableA device intended to be used in dentistry to measure the clearance between adjacent teeth (e.g., in orthodontic treatment during reproximation to relieve pressure points between teeth). The device is typically available in a set of stainless steel graduated gauges, typically with notches on the side to help with identification. Device thickness typically ranges from 0.1 mm to 0.5 mm. 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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00817524027563J&J Instruments37-303037-30302023-03-01

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