FDA.reportPublic FDA data

Sterile Drill Bit

Primary DI
B90831020150
Brand
Sterile Drill Bit
Company
Mainstream Medical Devices, LLC
Model
310-20-150
Catalog number
310-20-150
Device description
Single-Use, Non-cannulated Drill, Sterile
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90831020150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA 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, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Millimeter
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071513432
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90829211908Main-AXS Needle-Retropsoas292-11-908292-11-9082025-04-30
B90830825080Main-Mallet308-25-080308-25-0802025-04-04
B90831225080Main-Mallet312-25-080312-25-0802025-04-04
B90831625080Main-Mallet316-25-080316-25-0802025-04-04
B90831635080Main-Mallet316-35-080316-35-0802025-04-04
B908350011000Main-Mallet-Spinal Simplicity316-35-91135-0011-0002025-04-04
B908350008000Main-AXS Needle-Spinal Simplicity292-11-92035-0008-0002024-12-03
B908350009000Main-AXS Needle-Spinal Simplicity299-08-90035-0009-0002024-12-03
B90831020150907Sterile Drill Bit - RMR310-20-150-90707.20.QDS2024-08-09
B90831025150Sterile Drill Bit310-25-150310-25-1502024-08-09
B90831027150Sterile Drill Bit310-27-150310-27-1502024-08-09
B90831027150907Sterile Drill Bit - RMR310-27-150-90707.27.QDS2024-08-09
B90831032150Sterile Drill Bit310-32-150310-32-1502024-08-09
B90831032150907Sterile Drill Bit - RMR310-32-150-90707.32.QDS2024-08-09
B9081600051Main-Knife RIGID 21mm, Alphatec451-25-9011600-052024-03-02
B9081600060Main-Knife - Alphatec471-25-9011600-062024-03-02
B90847125901Main-Knife - Alphatec471-25-9011600-062024-02-21
B90845125901Main-Knife RIGID 21mm, Alphatec451-25-9011600-052023-07-12
B90847125193Main-Knife - Alphatec471-25-193471-25-1932024-02-21
B90847135193Main-Knife - Alphatec471-35-193471-35-1932024-02-21

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