FDA.reportPublic FDA data

gSource

Primary DI
00840314246349
Brand
gSource
Company
GSOURCE LLC
Model
gS 86.4530
Catalog number
gS 86.4530
Device description
Screwdriver 10" hex 4.0mm with notch POM hdl
Published
2020-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314246349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314246349008403142463498403142463490840314246349

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
008162518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314210364gSourcegS 29.4468gS 29.44682026-10-09
00840314252449gSourcegS 17.4346gS 17.43462026-10-09
00840314218117gSourcegS 40.6990gS 40.69902019-12-20
00840314243782gSourcegS 82.4740gS 82.47402020-02-27
00840314220448gSourcegS 42.7171gS 42.71712019-12-27
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314222237gSourcegS 45.5033gS 45.50332020-01-02
00840314222244gSourcegS 45.5043gS 45.50432020-01-02
00840314222251gSourcegS 45.5060gS 45.50602020-01-02
00840314231598gSourcegS 59.7670gS 59.76702020-02-14
00840314242723gSourcegS 81.3716gS 81.37162020-02-26
00840314242730gSourcegS 81.3717gS 81.37172020-02-26
00840314233073gSourcegS 65.7440gS 65.74402020-02-18
00840314243874gSourcegS 82.4870gS 82.48702020-02-27
00840314246295gSourcegS 86.4420gS 86.44202020-03-03
00840314221278gSourcegS 43.4120gS 43.41202019-12-31
00840314270344gSourcegS 40.1143gS 40.11432026-09-22
00840314269744gSourcegS 59.1800gS 59.18002025-05-05
00840314269690gSourcegS 49.2400gS 49.24002025-01-15
00840314269652gSourcegS 47.6299gS 47.62992024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150083466Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08
00199150076468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00199150076475Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-03
00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191753Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29