FDA.reportPublic FDA data

Simpex Drill Bit

Primary DI
B068DB1253251
Brand
Simpex Drill Bit
Company
SIMPEX MEDICAL, INC.
Model
DB-125-325
Catalog number
DB-125-325
Device description
"Twist Drill Bit .125"" DIA x 3.25"" LG"
Published
2019-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B068DB1253251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-851-9753info@simpexmedical.com

Regulatory Flags#

DUNS number
932637023
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B068B125121Simpex Steinmann PinB-125-12B-125-122016-09-26
B068D0781Simpex Steinmann PinD-078D-0782015-09-23
B068D078121Simpex Steinmann PinD-078-12D-078-122015-09-23
B068D07812S1Simpex Steinmann PinD-078-12SD-078-12S2015-09-23
B068D078S1Simpex Steinmann PinD-078-SD-078-S2015-09-23
B068D0931Simpex Steinmann PinD-093D-0932015-09-23
B068D093121Simpex Steinmann PinD-093-12D-093-122015-09-23
B068D09312S1Simpex Steinmann PinD-093-12SD-093-12S2015-09-23
B068D093S1Simpex Steinmann PinD-093-SD-093-S2015-09-23
B068D1091Simpex Steinmann PinD-109D-1092015-09-23
B068D109121Simpex Steinmann PinD-109-12D-109-122015-09-23
B068D10912S1Simpex Steinmann PinD-109-12SD-109-12S2015-09-23
B068D109S1Simpex Steinmann PinD-109-SD-109-S2015-09-23
B068D1251Simpex Steinmann PinD-125D-1252015-09-23
B068D125121Simpex Steinmann PinD-125-12D-125-122015-09-23
B068D12512S1Simpex Steinmann PinD-125-12SD-125-12S2015-09-23
B068D125S1Simpex Steinmann PinD-125-SD-125-S2015-09-23
B068D1401Simpex Steinmann PinD-140D-1402015-09-23
B068D140121Simpex Steinmann PinD-140-12D-140-122015-09-23
B068D14012S1Simpex Steinmann PinD-140-12SD-140-12S2015-09-23

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