FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8032805140
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 28-0514
Device description
"WARTENBERG PIN WHEEL 7"""
Published
2022-09-02
Public version status
New
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
B8032805140PrimaryHIBCC0

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
086618626
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B803904210SS0ORTHOMEDOM 90-4210-SSOM 90-4210-SS2026-05-08
B8037105136R0ORTHOMEDOM 71-0513-6ROM 71-0513-6R2026-05-01
B803KWIRE10C150S0ORTHOMEDKWIRE-10C-150SKWIRE-10C-150S2026-05-01
B8034802690ORTHOMEDOM 18-02692026-04-16
B8034803200ORTHOMEDOM 48-03202026-04-16
B8034803220ORTHOMEDOM 48-03222026-04-16
B8034803240ORTHOMEDOM 48-03242026-04-16
B8034803700ORTHOMEDOM 48-03702026-04-16
B8034803720ORTHOMEDOM 48-03722026-04-16
B8034803860ORTHOMEDOM 48-03862026-04-16
B8034803880ORTHOMEDOM 48-03882026-04-16
B8035202080ORTHOMEDOM 52-02082026-04-16
B8035202120ORTHOMEDOM 52-02122026-04-16
B8035202140ORTHOMEDOM 52-02142026-04-16
B8035202160ORTHOMEDOM 52-02162026-04-16
B8035202540ORTHOMEDOM 52-02542026-04-16
B8035202580ORTHOMEDOM 52-02582026-04-16
B8035202620ORTHOMEDOM 52-02622026-04-16
B8035202640ORTHOMEDOM 52-02642026-04-16
B8035202660ORTHOMEDOM 52-02662026-04-16

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
M368130911GrafcoGF HEALTH PRODUCTS, INC.GWY2021-06-09
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