FDA.reportPublic FDA data

N/A

Primary DI
B582160424X0
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
160424X
Catalog number
160424X
Device description
FORCEPS, RONGEUR, SURGICAL
Published
2020-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B582160424X0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags#

DUNS number
107043630
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B58206511500N/A6511506511502020-09-24
B58206513230N/A6513236513232020-09-24
B58206513300N/A6513306513302020-09-24
B58206542700N/A6542706542702020-09-24
B58206543800N/A6543806543802020-09-24
B5820655105N/A6551056551052020-09-24
B582065700PP0N/A065700PP065700PP2020-09-24
B582065705STRFA0N/A065705STRFA065705STRFA2020-09-24
B5820705000N/A70500705002020-09-24
B582070609STFRA0N/A070609STFRA070609STFRA2020-09-24
B5820800800N/A80080800802020-09-24
B5820800810N/A80081800812020-09-24
B582080090450N/A800904580090452020-09-24
B582080090620N/A800906280090622020-09-24
B582080091620N/A800916280091622020-09-24
B5820800950N/A80095800952020-09-24
B58208009910N/A8009918009912020-09-24
B58208009930N/A8009938009932020-09-24
B58208009940N/A8009948009942020-09-24
B58208009950N/A8009958009952020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219229PRINCETONPrinceton Medical Group, Inc.EMH2026-03-12
00810158219076PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219083PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MMW.H. Holden, Inc.EMH2026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MMW.H. Holden, Inc.EMH2026-01-06
B7688441020Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B7688457751630Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362280Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362360Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
08809596474019Kerrison Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
B76884332520Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
B76885300040Buxton BioMedicalBuxton Biomedical IncEMH2025-11-13
00198506084522ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084539ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084546ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084560ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084577ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084584ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084591ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
00198506084607ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
B76884850320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884850420Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884850520Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30
B76884852320Buxton BioMedicalBuxton Biomedical IncEMH2025-07-30