FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094004571
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901067
Catalog number
44900-C
Device description
Welch Allyn Green Series 900 Procedure Light with Ceiling Mount; Six White LEDs, 80,000 LUX @ 24 in/61 cm, 5,500° K; Touchless Controls; 100-240 V, 50-60 Hz AC, IEC Plug Type-B
Published
2022-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSRLight, headband, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSRLight, Headband, SurgicalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031548000LED HEADLIGHTWelch Allyn, Inc.2003-08-11FSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094004571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094004571007320940045717320940045710732094004571

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags#

DUNS number
198227881
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535020120Brasseler EZXIMEDICOM CO., LTD.FSR2025-10-10
00848657071017Light, Headband, SurgicalNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FSR2023-10-12
00732094004564Welch Allyn, Inc.WELCH ALLYN, INC.FSR2022-05-19
10381780490708Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490715Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490746Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490784Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490821Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490869Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490906Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490944Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490982Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491026Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491064Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491071Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491088Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491095Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
04048551124444n.a.Karl Storz GmbH & Co. KGFSR2016-09-23
04048551124468n.a.Karl Storz GmbH & Co. KGFSR2016-09-23
00732094072150Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094072167Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094073065Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094073072Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094002485Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-20
00732094072143Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-20
00732094001679Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094002492Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094002591Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094041835Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094071818Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17