FDA.reportPublic FDA data

Bone Curette

Primary DI
00846338006822
Brand
Bone Curette
Company
ELLIQUENCE, LLC
Model
11-3008
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRRScissors, Orthopedic, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846338006822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338006822008463380068228463380068220846338006822

GMDN Terms#

Term, Definition table
TermDefinition
Spinal endoscopic-access systemAn assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
019872358
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
00846338003869Surgi-Max Drill16-02002026-05-11
00846338003876Surgi-Max Drill16-02012026-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622838All Purpose ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
08961104622845Crown ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
04059453049223Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2026-03-02
00810207783954Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783961Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783978Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783985Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
04059453054517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2025-08-28
00757770505784Bausch + LombBausch & Lomb IncorporatedHRR2025-08-08
00194613061821MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613096328MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114121MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114671MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114688MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613115135MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613120092MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
B35675470110American MedicalsAmerican MedicalsHRR2025-06-30
B35675475110American MedicalsAmerican MedicalsHRR2025-06-25
00194613096311MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613096342MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613115142MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00846338005634Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005641Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005658Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005665Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005672Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338002237Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338003111Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005214Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005238Bone CuretteELLIQUENCE, LLCHRR2025-01-09