FDA.report

Welch Allyn, Inc.

Primary DI
00732094084207
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901025
Catalog number
23857
Device description
Welch Allyn 3.5 V Halogen HPX Throat Illuminator Accessory for MacroView Otoscopes (#23820, #26035, #26535); Otoscope Not Included
Published
2023-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HJNTransilluminator, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094084207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094084207007320940842077320940842070732094084207

GMDN Terms

TermDefinition
Skin transilluminator, line-poweredA hand-held, mains electricity (AC-powered) device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. It can use varying forms of light depending upon the specific application. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.

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
true
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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