FDA.report

Paul Banditt

Primary DI
D955CAL9S1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
CAL9S
Device description
PAUL BANDITT 9S CASTRO VIEJO CALIPER, STRAIGHT, 0-40MM, 9CM
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
EILGauge, Depth, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D955CAL9S1PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. 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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D955BCU2R2L1Paul BandittBCU2R2L 2023-12-11
D955BCU71001Paul BandittBCU7100 2023-12-11
D955BCU71101Paul BandittBCU7110 2023-12-11
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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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