FDA.report

Welch Allyn, Inc.

Primary DI
00732094014129
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901037
Catalog number
20510H
Device description
Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Headband, Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, IEC Plug Type-A
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HJHLoupe, binocular, low power

Product Code Classifications

CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094014129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094014129007320940141297320940141290732094014129

GMDN Terms

TermDefinition
Mobile examination/treatment room lightA mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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