Home GUDID 00732094088472 Welch Allyn, Inc.
Primary DI 00732094088472
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901080
Catalog number 12861
Device description Klinic Pkt. 2.5 V Ophthalmoscope, Handle, and Case
Published 2019-09-30
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 Product Codes# Code, Name table Code Name ERA OTOSCOPE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00732094088472 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00732094088472 00732094088472 732094088472 0732094088472
GMDN Terms# Term, Definition table Term Definition Direct ophthalmoscope, battery-powered A battery-powered, hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of a built-in light source that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single view hole, and a dial containing several lenses of different powers that can be alternated by the examiner while viewing. It produces an upright, or unreversed, image of about 15 times magnification. Batteries are housed in the instrument’s handle; supplemental devices (e.g., spare light bulbs) may be included.
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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00732094055245 Welch Allyn, Inc. 901001 SM2551 2026-03-06 00887761976283 Life2000 MS-01-0125 2026-02-09 00887761978041 Life2000 MS-01-0121 2026-02-09 00732094360363 Welch Allyn, Inc. 901144 QS-6AA-AEAAA 2026-02-03 00732094360370 Welch Allyn, Inc. 901144 XSCRIBE-6AA-ACAAA 2026-02-03 00732094360295 Welch Allyn, Inc. 901204 v7.4.2 E10001 2025-12-18 00732094357929 Welch Allyn, Inc. 901026 71-XM2LXE 2025-11-25 00732094358933 Welch Allyn, Inc. 901203 C360KIT95RXTBWLJBP 2025-11-24 00732094358957 Welch Allyn, Inc. 901203 C360KIT95MXTBWLJBP 2025-11-24 00732094358971 Welch Allyn, Inc. 901203 C360KIT95CXTBWLJBP 2025-11-24 00732094358988 Welch Allyn, Inc. 901203 C360KIT95CXTBMBJX 2025-11-24 00732094237740 Welch Allyn, Inc. 901049 CP150A 2025-09-22 00732094356366 Welch Allyn, Inc. 901006 9293-046-57 2025-09-22 00732094356373 Welch Allyn, Inc. 901006 9293-046-55 2025-09-22 00732094356380 Welch Allyn, Inc. 901006 9293-046-06 2025-09-22 00732094356397 Welch Allyn, Inc. 901006 9293-046-05 2025-09-22 00732094356403 Welch Allyn, Inc. 901006 9293-046-04 2025-09-22 00732094356410 Welch Allyn, Inc. 901006 9293-046-03 2025-09-22 00732094309225 Welch Allyn, Inc. 901057 44XT 2021-04-26 06932825304237 Welch Allyn, Inc. 901123 2000 PLUS-A 2025-08-08
Other Devices Sharing Product Codes# 
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