FDA.report

J&J Instruments

Primary DI
00817524023503
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
08-070
Device description
GOLD KNIFE U.S.C. #2
Published
2019-10-16
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
EMOKnife, Periodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1
EMOKnife, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524023503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524023503008175240235038175240235030817524023503

GMDN Terms

TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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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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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