FDA.reportPublic FDA data

Variable Polarizing Hood

Primary DI
00850033167122
Brand
Variable Polarizing Hood
Company
Globalmed Holdings, LLC
Model
GMD55100010
Catalog number
GMD55100010
Device description
An instrument that eliminates unwanted glare from surfaces that are being examined.
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PEQAccessories To Examination Light

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEQAccessories To Examination LightGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131338000DERMA HOODGlobalmedia Group, LLC2013-07-10PEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033167122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033167122008500331671228500331671220850033167122

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical camera lens, otoscopicA non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the external auditory canal and tympanic membrane. It typically facilitates recording of the colour, position, and translucency of the tympanic membrane and is intended to be used with a disposable speculum to limit patient cross-infection. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103201849
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085003316723ClinicalAccess® Kiosk1.01CAK0012025-06-26
00850033167221ClinicalAccess Pro Connect1.01CAP001-C01 / 1CAP001-C022025-06-26
00850033167184Smartest Persona II Multi Blood Glucose Monitoring System62762024-12-02
00850033167115eNcountereNcounter2023-12-12
00850033167108ClearStethGSW30100103GSW301001032023-12-08
00850033167139First Exam StationFirst Exam Station2023-12-08
00850033167146Total VitalsUSBGMR507000102023-12-08
00850033167153Total VitalsBluetoothGMR507000202023-12-08
00850033167160Total VitalsDual - BT & USBGMR507000302023-12-08
00850033167177Total ECGGMD50610001GMD506100012023-12-08
00850033167009TotalExam® 3.2 CameraGMD5504HD58GMD5504HD582023-08-04
00850033167016CAS Lite®1CSL0011CSL0012023-08-04
00850033167023TotalExam® Lite, 2.0 GMD5505HD21GMD5505HD212023-08-04
00850033167030TotalExam® Oto 2.0GMD5505HD22GMD5505HD222023-08-04
00850033167047TotalExam® Lite & Oto 2.0GMD5505HD20GMD5505HD202023-08-04
00850033167054Transportable Exam Station (TES)1TES0061TES0062023-08-04
00850033167061Clinical Access® Station (CAS)1CAS0041CAS0042023-08-04
00850033167078WallDoc®1WDC0031WDC0032023-08-04
00850033167085Next Exam Station (NES)GMR12150000GMR121500002023-08-04
00850033167092LiteExam® Station (LES)1LES0011LES0012023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205044372Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205044389Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205044396Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205044402Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205044419Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205044426Valo XULTRADENT PRODUCTS, INC.PEQ2025-12-04
00883205035561Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-21
00883205032997VALOULTRADENT PRODUCTS, INC.PEQ2025-08-20
00883205042873Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042880Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042897Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042903Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042910Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042927Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205042934Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043269Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043276Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043283Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043290Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043306Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043313Valo X ULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043320Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205043351Valo XULTRADENT PRODUCTS, INC.PEQ2025-08-14
00883205032980VALOULTRADENT PRODUCTS, INC.PEQ2025-03-11
00883205034168VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034175VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034182VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034199VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034205VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205039163VALOULTRADENT PRODUCTS, INC.PEQ2023-11-09