FDA.report

Buxton BioMedical

Primary DI
B7688876050
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
88-7605
Catalog number
88-7605
Device description
Smith-Peterson Rngr,5mm,str.
Published
2023-03-24
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

Related Records

Product Codes

CodeName
EMHForceps, Rongeur, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B7688876050PrimaryHIBCC0

GMDN Terms

TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
808385207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

Other Devices From This Company

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B76885362280Buxton BioMedical853-6228853-62282025-12-31
B76885362360Buxton BioMedical853-6236853-62362025-12-31
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B76885300040Buxton BioMedical853-0004853-00042025-11-13
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B7685255190Buxton BioMedical52-551952-55192025-09-24
B7685257320Buxton BioMedical52-573252-57322025-09-24
B7685410380Buxton BioMedical54-103854-10382025-09-24
B7685410410Buxton BioMedical54-104154-10412025-09-24

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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
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08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
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08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
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00198506084539ELMED INCORPORATEDELMED INCORPORATEDEMH2025-08-11
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