FDA.reportPublic FDA data

MERCURY

Primary DI
00840606101851
Brand
MERCURY
Company
SPINAL ELEMENTS, INC.
Model
63585-070
Device description
8.5MM X 70MM CLOSED HEAD POLYAXIAL SCREW
Published
2019-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder CancerHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606101851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606101851008406061018518406061018510840606101851

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
DM 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
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810088653155Goblin Pedicle Screw SystemMEDYNUS, INC.NBK2021-10-07
08806162165852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165951AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165968AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165975AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165982AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165999AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166002AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166019AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166026AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166262AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166279AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166286AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166293AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166309AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166316AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166323AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166330AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166347AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166354AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166361AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07