FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955CAL9S1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D955CRO1081Paul BandittCRO108 2023-12-11
D955CRO27081Paul BandittCRO2708 2023-12-11
D955CRO27091Paul BandittCRO2709 2023-12-11
D955CRO2709I1Paul BandittCRO2709I 2023-12-11
D955CRO3T1Paul BandittCRO3T 2023-12-11
D955CRO49281Paul BandittCRO4928 2023-12-11
D955CRO49311Paul BandittCRO4931 2023-12-11
D955CROPORI1Paul BandittCROPORI 2023-12-11
D955CROPORL1Paul BandittCROPORL 2023-12-11
D955CROPORU1Paul BandittCROPORU 2023-12-11
D955CROTIPA1Paul BandittCROTIPA 2023-12-11
D955CROTIPB1Paul BandittCROTIPB 2023-12-11
D955CROTIPC1Paul BandittCROTIPC 2023-12-11
00860011605706Surgi-StopSDWD-01 2024-01-29
10860011605703Surgi-StopSDWD-01 2024-01-29
D9553300KEY1Paul Banditt3300-KEY 2023-12-11
D95543411Paul Banditt434-1 2023-12-11
D955BC169511Paul BandittBC1695-12023-12-11
D955BC169521Paul BandittBC1695-2 2023-12-11
D955BCU0R0L1Paul BandittBCU0R0L 2023-12-11

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Primary DI, Brand, Company table
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00810213814833EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814840EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814857EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814826EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-18
00810135961233ToejackNVision Biomedical Technologies, Inc.EIL2026-07-29
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G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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