FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955SUCYH1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
SUCYH
Device description
BANDITT SUCYH YANKAUER HANDLE, 27cm
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
KCBTube, Tonsil Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955SUCYH1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, reusableA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B382SD9194441080Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD920223100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9204111140Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9227771100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD4930130450Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD61042070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD6786020Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430081A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD91143014A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911431107A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511180Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511490Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511500Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511680Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860310Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860320Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860330Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860340Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430150Surgical DirectSurgical Direct, Inc.KCB2025-12-02
B382SD471400820Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114311000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114312000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114511830Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911451185A0Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911500010Surgical DirectSurgical Direct, Inc.KCB2025-11-05