FDA.report

Welch Allyn, Inc.

Primary DI
00732094074130
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901025
Catalog number
43300
Device description
Welch Allyn 3.5 V Curved Transilluminator
Published
2023-08-17
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
HJNTransilluminator, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094074130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094074130007320940741307320940741300732094074130

GMDN Terms

TermDefinition
Visible-light skin transilluminatorAn electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or 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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