FDA.report

JETIP Wrench

Primary DI
08800019110408
Brand
JETIP Wrench
Company
B& L Biotech, inc.
Model
WR01
Published
2022-10-14
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
JETPick, Massaging

Product Code Classifications

CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800019110408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800019110408088000191104088800019110408

GMDN Terms

TermDefinition
Dental ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687338285
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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08800019151029BL Clamp CLAPM12A2025-07-18
08800019151036BL Clamp CLAMP13A2025-07-18
08800019151043BL Clamp CLAMP2012025-07-18
08800019151050BL Clamp CLAMP2102025-07-18
08800019151067BL Clamp CLAMP2112025-07-18
08800019116608NeoGlide Resin InstrumentsNGR#12025-06-18
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08800019151289PVS TipPVSA2025-04-30
08800019151296PVS TipPVSE2025-04-30
08800019151302PVS TipPVSC2025-04-30
08800019151548Endodontic ExplorerENEX2025-04-30
08800019151555Dental Mirror HandleDMHG2025-04-30
08800019151562Pro Endo Mirror PEM2025-04-30
08800019151586Dental MirrorDMF42025-04-30
08800019151593DB TipDB-0A2025-04-30
08800019151609DB TipDB-3A2025-04-30
08800019151616DB TipDB-0E2025-04-30
08800019151623DB TipDB-3E2025-04-30
08800019151630DS TipDS-XLA2025-04-30

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08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
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08800019151630DS TipB& L Biotech, inc.JET2025-04-30
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