FDA.reportPublic FDA data

SEEG SHORT BOLT DRIVER

Primary DI
00888233048378
Brand
SEEG SHORT BOLT DRIVER
Company
BIOMET MICROFIXATION, INC
Model
SEEGINST02
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXLScrewdriver, Skullplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233048378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233048378008882330483788882330483780888233048378

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
046189866
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
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30
00888233077200PECTUS BLU (TM)78-808278-80822024-09-30
00888233077224PECTUS BLU (TM)78-830078-83002024-09-30
00888233077231PECTUS BLU (TM)78-835078-83502024-09-30
00888233077248PECTUS BLU (TM)78-840078-84002024-09-30
00888233077255PECTUS BLU (TM)78-845078-84502024-09-30
00888233077279PECTUS BLU (TM)78-855078-85502024-09-30
00888233028776PECTUS BLU (TM)78-001078-00102022-02-09
00888233028783PECTUS BLU (TM)78-001178-00112022-02-09
00888233028790PECTUS BLU (TM)78-001278-00122022-02-09
00888233028806PECTUS BLU (TM)78-002078-00202022-02-09
00888233028813PECTUS BLU (TM)78-003078-00302022-02-09
00888233028837PECTUS BLU (TM)78-004078-00402022-02-09
00888233028844PECTUS BLU (TM)78-005078-00502022-02-09
00888233028851PECTUS BLU (TM)78-005178-00512022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610733850365OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850372OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850464OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850556OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850563OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850617OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
06903195298570Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
06903195298587Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
04056481145606HEX SCREWDRIVER T-HANDLE (2.5 MM)Brainlab SEGXL2023-10-19
00888233048361SEEG LONG BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00856482008467KLS E-Coupling AdapterPRO-DEX, INC.GXL2023-05-23
04056481144708Skull Reference Screwdriver HandleBrainlab SEGXL2023-05-05
04056481144715Skull Reference Screwdriver BladeBrainlab SEGXL2023-05-05
G28435301ScrewdriverNeurovention LLCGXL2022-06-21
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PRO-DEX, INC.GXL2022-04-01
00856482008269MatrixPRO II Handpiece LoanerPRO-DEX, INC.GXL2022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPRO-DEX, INC.GXL2022-04-01
00860540000225MatrixPRO Driver LoanerPRO-DEX, INC.GXL2022-04-01
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEPRO-DEX, INC.GXL2022-03-29
00862377000140BATTERY PACK, KLS-SD-1000, SINGLEPRO-DEX, INC.GXL2022-03-29
00856482008016KLS E-Coupling AdapterPRO-DEX, INC.GXL2022-03-29
00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29
00856482008207Pro-Dex Surgical DriverPRO-DEX, INC.GXL2022-03-29