FDA.reportPublic FDA data

STILLE-HORSLEY BONE CUTTER

Primary DI
00192896027930
Brand
STILLE-HORSLEY BONE CUTTER
Company
SONTEC INSTRUMENTS, INC.
Model
315-760
Catalog number
315-760
Device description
STILLE-HORSLEY BONE CUTTER S-SHAPED UP-ANGLE JAW
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896027930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896027930001928960279301928960279300192896027930

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.5Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
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00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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