FDA.reportPublic FDA data

gSource

Primary DI
00840314200280
Brand
gSource
Company
GSOURCE LLC
Model
gS 11.6140
Catalog number
gS 11.6140
Device description
"Wartenberg Pin Wheel 7"""
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWYPinwheel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWYPinwheelNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314200280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314200280008403142002808403142002800840314200280

GMDN Terms#

Term, Definition table
TermDefinition
Pinwheel aesthesiometerA manual stimulator designed to determine tactile sensibility by testing a patient's discrimination of diameter in rods mounted on a disc. It typically consists of a disc, with protruding rods that differ in diameter, mounted on a rotary pin; the disc is manually rotated on the patient's skin by moving an integral handle at the proximal end. The rods may be sharply pointed for testing pain sensation. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. 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
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24
00840314238627gSourcegS 75.9307gS 75.93072025-11-24
00840314238634gSourcegS 75.9308gS 75.93082025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586G5541360Novo SurgicalNOVO SURGICAL, INC.GWY2023-12-18
G586G95541360Novo SurgicalNOVO SURGICAL, INC.GWY2023-12-18
00817524029956J&J InstrumentsJ & J INSTRUMENTS INCGWY2023-06-08
00840183505394BR Surgical, LLCBR Surgical, LLCGWY2023-03-28
10665973022786Tech-MedDukal LLCGWY2022-12-06
20665973022783Tech-MedDukal LLCGWY2022-12-06
B8032805140ORTHOMEDORTHO-MED, INC.GWY2022-09-02
M368130911GrafcoGF HEALTH PRODUCTS, INC.GWY2021-06-09
04046826046439MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWY2020-09-24
00612479142855McKessonMCKESSON MEDICAL-SURGICAL INC.GWY2018-12-05
00612479141285McKessonMCKESSON MEDICAL-SURGICAL INC.GWY2018-11-12
00192896024380WARTENBERG PIN WHEELSONTEC INSTRUMENTS, INC.GWY2018-09-14
10381780357612Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-09-12
H83412260Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-09-12
10885403081033V. MuellerSTERIS CORPORATIONGWY2018-08-30
10381780487333Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-08-20
H834MH12260Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-08-20
10381780181484Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-01-31
M2741801301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-01-31
10381780414483Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-01-22
H834V912260Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWY2018-01-22
00634782001827ADC®AMERICAN DIAGNOSTIC CORPGWY2016-09-21
00634782036409ADC®AMERICAN DIAGNOSTIC CORPGWY2016-09-21
00634782501815ADC®AMERICAN DIAGNOSTIC CORPGWY2016-09-21
00634782536251ADC®AMERICAN DIAGNOSTIC CORPGWY2016-09-21