FDA.reportPublic FDA data

gSource

Primary DI
00840314227232
Brand
gSource
Company
GSOURCE LLC
Model
gS 52.0100
Catalog number
gS 52.0100
Device description
"Interchange Handle 7"" plastic, black "
Published
2020-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314227232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314227232008403142272328403142272320840314227232

GMDN Terms#

Term, Definition table
TermDefinition
Chisel/osteotome blade handleA hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
1
Premarket exempt
true
Lot or batch
true
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
00840314246349gSourcegS 86.4530gS 86.45302020-03-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396389TruTORQ Offset T-Handle Sterile, Single UseEca Medical InstrumentsLXH2026-10-20
10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16