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
00840314270290gSourcegS 51.7750gS 51.77502026-08-07
00840314269751gSourcegS 53.4800gS 53.48002025-06-16
00840314269737gSourcegS 81.8607gS 81.86072025-05-05
00840314269584gSourcegS 82.7910gS 82.79102024-05-22
00840314263261gSourcegS 86.7506gS 86.75062026-07-24
00840314263278gSourcegS 86.7516gS 86.75162026-07-24
00840314263285gSourcegS 86.7571gS 86.75712026-07-24
00840314263353gSourcegS 86.7581gS 86.75812026-07-24
00840314263421gSourcegS 86.7591gS 86.75912026-07-24
00840314263704gSourcegS 86.9401gS 86.94012026-07-24
00840314263773gSourcegS 86.9451gS 86.94512026-07-24
00840314263841gSourcegS 86.9461gS 86.94612026-07-24
00840314233066gSourcegS 65.7431gS 65.74312020-02-18
00840314263636gSourcegS 86.9391gS 86.93912026-07-17
00840314264190gSourcegS 86.9521gS 86.95212026-07-17
00840314264268gSourcegS 86.9531gS 86.95312026-07-17
00840314264404gSourcegS 86.9551gS 86.95512026-07-17
00840314264473gSourcegS 86.9561gS 86.95612026-07-17
00840314264541gSourcegS 86.9571gS 86.95712026-07-17
00840314264619gSourcegS 86.9581gS 86.95812026-07-17

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