FDA.reportPublic FDA data

Surgi-Max Drill

Primary DI
00846338003876
Brand
Surgi-Max Drill
Company
ELLIQUENCE, LLC
Model
16-0201
Device description
Articulating Diamond Burr, One (1) Sterile, Single Use, D: 3.7mm
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338003876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338003876008463380038768463380038760846338003876

GMDN Terms#

Term, Definition table
TermDefinition
Spinal decompression cutting handpiece/endpieceA sterile, hand-held, powered surgical instrument designed to excise spinal (central canal and foramen) soft and hard tissue to relieve pressure (decompression) on adjacent nerve tissue, especially in the case of spinal stenosis or degenerative disk disease (DDD). It typically consists of a handpiece and integral metal (e.g., stainless steel) shaft, which may have a straight or curved tip, terminating in an exposed or shielded rotary cutting burr. The rotary action is provided by a suitable electrically or pneumatically-powered motor attached to the proximal end of the handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
019872358
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846338003869Surgi-Max Drill16-02002026-05-11
00846338004422Trigger-Flex Quad Pro Bipolar SystemDTFQM-132026-05-11
00846338004439Trigger-Flex Quad Pro Bipolar SystemDTFQM-342026-05-11
00846338004446Trigger-Flex Quad Pro Bipolar SystemDTFQM-352026-05-11
00846338004453Trigger-Flex Quad Pro Bipolar SystemDTFQM-362026-05-11
00846338004460Trigger-Flex Quad Pro Bipolar SystemDTFQM-382026-05-11
00846338004477Trigger-Flex Quad Pro Bipolar SystemDTFQM-392026-05-11
00846338004484Bipolar Forceps J12026-05-11
00846338004491COBBRARF-COBB/XL2026-05-11
00846338004507COBBRARF-COBB/S2026-05-11
00846338004514COBBRARF-COBB/XS2026-05-11
00846338004521Endiscope10-20162026-05-11
00846338004538Endiscope10-20172026-05-11
00846338004545Endiscope10-20182026-05-11
00846338004552Endiscope10-20192026-05-11
00846338004569Endiscope10-20242026-05-11
00846338004576Endiscope10-20252026-05-11
00846338004583Endiscope10-20262026-05-11
00846338004590Endiscope10-20272026-05-11
00846338004606Endiscope10-20282026-05-11

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