FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955HEMKCR1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
HEMKCR
Device description
Paul Banditt Hemostat, KCR Kelly, curved 14.5cm
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
EMDHemostat, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955HEMKCR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clamp manipulation forcepsA hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. 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
Primary DIBrandCompanyProduct codePublished
G149TBSB7410TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7420TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7430TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7440TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7450TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7460TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7470TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7480TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7490TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149NP380760NPSACME ENTERPRISE.EMD2026-05-01
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
08800075610102OSUNG MNDOSUNG MND Co., Ltd.EMD2025-11-03
00841336101630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00841336101647Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
D928140052DLC0HEMOSTAT JACKSON, SLIGHT CURVED, DLC, 19 CMW.H. Holden, Inc.EMD2025-06-24
00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726379GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726386GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726393GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
00842517111417Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517111424Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112216Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
D928140051190HEMOSTAT CRAFOORD SLIGHT CURVED 19CMW.H. Holden, Inc.EMD2024-12-18
00840343725099GEN2SURGIX MEDICAL LLCEMD2024-11-07
00840343724702GEN2SURGIX MEDICAL LLCEMD2024-10-25
00840343724061GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343724078GEN2SURGIX MEDICAL LLCEMD2024-10-01