FDA.report

Welch Allyn, Inc.

Primary DI
00732094087765
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901024
Catalog number
18204
Device description
Welch Allyn Elite 3.5 V Halogen HPX Streak Retinoscope; Power Handle Not Included
Published
2020-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HKMRetinoscope, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094087765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094087765007320940877657320940877650732094087765

GMDN Terms

TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

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
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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04053755202508BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HKM2023-08-17
04053755191673BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
00732094098914Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
00732094098952Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
04045396010819ri-scope® retinoscope head slit XL 3.5 VRudolf Riester GmbHHKM2021-01-28
04045396129931ri-scope® retinoscope head slit XL 3.5 V,Rudolf Riester GmbHHKM2021-01-28
04045396140974ri-vision with retinoscope slit XL 3.5 V, C-handleRudolf Riester GmbHHKM2021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
04045396182660ri-vision with slit retinoscope XL/LED 3,5V/120V,Rudolf Riester GmbHHKM2021-01-28
04045396182783ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
00732094087703Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087772Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087789Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094176131Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
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06945095536000zumaxZumax Medical Co., LTDHKM2018-08-27
06945095531180zumaxZumax Medical Co., LTDHKM2018-07-31
00851158007508Eli EzerU.S. OPHTHALMIC, L.L.C.HKM2018-02-09
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00732094169584Welch Allyn, Inc.WELCH ALLYN, INC.HKM2018-01-09
00732094146073Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-21
00732094087710Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17
00732094087734Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17
00732094087741Welch Allyn, Inc.WELCH ALLYN, INC.HKM2016-09-17