FDA.reportPublic FDA data

Grafco

Primary DI
M368130911
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
1309-1
Catalog number
1309-1
Device description
"CHROME WARTENBERG PINWHEEL, 7"""
Published
2021-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
M368130911PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

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
04046826046439MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGWY2020-09-24
00840314200280gSourceGSOURCE LLCGWY2019-08-30
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