FDA.reportPublic FDA data

Guide, surgical, instrument

Primary DI
00816342025249
Brand
Guide, surgical, instrument
Company
PARCUS MEDICAL LLC
Model
10614U
Device description
5mm DRILL GUIDE PIN
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816342025249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342025249008163420252498163420252490816342025249

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
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089542548AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543378AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543682AMPLITUDEAMPLITUDE SASFZX2026-07-29
03700569674335Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21