FDA.report

J&J Instruments

Primary DI
00817524023138
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
07-820
Device description
BAND PUSHER/SCALER #300S
Published
2019-10-10
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
ECSPusher, Band, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524023138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524023138008175240231388175240231380817524023138

GMDN Terms

TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. 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

Primary DIBrandModelCatalogPublished
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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