FDA.reportPublic FDA data

BIT, DRILL

Primary DI
00816342024600
Brand
BIT, DRILL
Company
PARCUS MEDICAL LLC
Model
11338
Device description
5.5mm Cannulated Reamer
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00816342024600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342024600008163420246008163420246000816342024600

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859961950
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816342022033Graft Fixation System200422025-09-16
00816342022040Graft Fixation System200492025-09-16
00816342022057Graft Fixation System200532025-09-16
00816342022064Graft Fixation System200542025-09-16
00816342022071Graft Fixation System200552025-09-16
00816342022088Graft Fixation System200562025-09-16
00816342022095Graft Fixation System200592025-09-16
00816342022101Graft Fixation System200602025-09-16
00816342023887Graft Fixation System200462025-09-16
00816342023900Graft Fixation System200502025-09-16
00816342023955Graft Fixation System20042S2025-09-16
00816342024204Graft Fixation System20049S2025-09-16
00816342024211Graft Fixation System20035S2025-09-16
00816342024228Graft Fixation System20055S2025-09-16
00816342024235Graft Fixation System20054S2025-09-16
00816342024242Graft Fixation System20059S2025-09-16
00816342024259Graft Fixation System20053S2025-09-16
00816342024266Graft Fixation System20056S2025-09-16
00816342024273Graft Fixation System20032S2025-09-16
00816342024280Graft Fixation System20034S2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089526579AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528047AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528344AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089528351AMPLITUDEAMPLITUDE SASHTW2026-07-29
03701089529976AMPLITUDEAMPLITUDE SASHTW2026-07-29
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