FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955NHCITWCR1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
NHCITWCR
Device description
BANDITT MICRO NEEDLE HOLDER WITH LOCK, STRAIGHT HANDLE, TC INSERT, 17.5MM, CURVED For suture size 4/0-8/0
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955NHCITWCR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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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00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
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08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21