FDA.reportPublic FDA data

J & J INSTRUMENTS INC

Primary DI
00817524021028
Brand
J & J INSTRUMENTS INC
Company
J & J INSTRUMENTS INC
Model
03-450
Catalog number
03-450
Device description
WARD CARVER #1
Published
2018-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIKCarver, Wax, Dental
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817524021028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524021028008175240210288175240210280817524021028

GMDN Terms#

Term, Definition table
TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.625Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
783328149
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524027846J&J Instruments42-123042-12302023-03-01
00817524027853J&J Instruments42-127042-12702023-03-01
00817524022865J&J Instruments07-2002019-10-07
00817524020328J & J INSTRUMENTS02-010 02-010 2018-05-31
00817524020335J & J INSTRUMENTS02-02002-0202018-05-31
00817524020359J & J INSTRUMENTS02-10102-1012018-05-31
00817524020397J & J INSTRUMENTS02-275 02-275 2018-05-31
00817524020403J & J INSTRUMENTS02-28502-2852018-05-31
00817524020410J & J INSTRUMENTS02-28602-2862018-05-31
00817524020427J & J INSTRUMENTS02-28702-2872018-05-31
00817524020434J & J INSTRUMENTS02-28802-2882018-05-31
00817524020441J & J INSTRUMENTS02-29102-2912018-05-31
00817524020458J&J Instruments02-292 02-292 2018-10-16
00817524020465J&J Instruments02-293 02-293 2018-10-16
00817524020472J&J Instruments02-294 02-294 2018-10-16
00817524020489J&J Instruments02-295 02-295 2018-10-16
00817524020496J&J Instruments02-296 02-296 2018-10-16
00817524020618J & J INSTRUMENTS INC02-50002-5002018-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB8080TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8090TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
08800075627551OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
08800075627568OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
08800075627575OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
08800075627582OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
08800075627599OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
08800075627667OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
10889950005375HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
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10889950005405HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
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10889950005429HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12