FDA.report

Paul Banditt

Primary DI
D955PLIBAADE1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
PLIBAADE
Device description
PAUL BANDITT BAADE CROWN/COPPER RING REMOVAL PLIER, STRAIGHT, 15CM
Published
2023-12-11
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
JEXPlier, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D955PLIBAADE1PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
177465051
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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D955BCU1R1L1Paul BandittBCU1R1L 2023-12-11
D955BCU2R2L1Paul BandittBCU2R2L 2023-12-11
D955BCU71001Paul BandittBCU7100 2023-12-11
D955BCU71101Paul BandittBCU7110 2023-12-11
D955BCU71201Paul BandittBCU7120 2023-12-11
D955BCU72521Paul BandittBCU7252 2023-12-11
D955BCU72541Paul BandittBCU7254 2023-12-11
D955BCU9361Paul BandittBCU936 2023-12-11
D955BCUM11Paul BandittBCUM1 2023-12-11
D955BCUM21Paul BandittBCUM2 2023-12-11
D955BCUM241Paul BandittBCUM24 2023-12-11
D955BCUM31Paul BandittBCUM3 2023-12-11
D955BCUM41Paul BandittBCUM4 2023-12-11
D955BCUM7L1Paul BandittBCUM7L 2023-12-11

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