FDA.report

J&J Instruments

Primary DI
00817524022964
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
07-300
Device description
TOFFLEMIRE UNIVERSAL ADULT
Published
2019-10-08
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
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524022964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524022964008175240229648175240229640817524022964

GMDN Terms

TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. 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

Other Devices From This Company

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00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524029956J&J Instruments18-604018-60402023-06-08
00817524026740J&J Instruments31-100031-10002023-03-01
00817524026757J&J Instruments31-101031-10102023-03-01
00817524026764J&J Instruments31-117031-11702023-03-01
00817524026771J&J Instruments31-118031-11802023-03-01
00817524026788J&J Instruments31-119031-11902023-03-01
00817524026795J&J Instruments33-200033-20002023-03-01
00817524026801J&J Instruments33-303033-30302023-03-01
00817524026818J&J Instruments33-306533-30652023-03-01
00817524026825J&J Instruments33-410033-41002023-03-01
00817524026832J&J Instruments33-415033-41502023-03-01
00817524026849J&J Instruments33-523033-52302023-03-01
00817524026856J&J Instruments33-526033-52602023-03-01
00817524026863J&J Instruments33-615033-61502023-03-01
00817524027532J&J Instruments37-500537-50052023-03-01
00817524027549J&J Instruments37-301037-30102023-03-01
00817524027556J&J Instruments37-302037-30202023-03-01
00817524027563J&J Instruments37-303037-30302023-03-01

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06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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