FDA.report

Welch Allyn, Inc.

Primary DI
00732094323948
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901124
Catalog number
RV700TUD-B
Device description
RV700 IMAGER SET TRADE-UP DISTRIBUTOR
Published
2019-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PJZCamera, ophthalmic, general-use

Product Code Classifications

CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094323948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094323948007320943239487320943239480732094323948

GMDN Terms

TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

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
false
Serial number
true
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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