FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094144086
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901014
Catalog number
52640-B
Device description
Welch Allyn Disposable Sheaths for Green Series Exam Light IV; Qty. 25
Published
2023-04-25
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCWTransformer, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCWTransformer, EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094144086PackageGS15In Commercial Distribution
00732094147629PrimaryGS10
00732094247053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094144086007320941440867320941440860732094144086
00732094147629007320941476297320941476290732094147629
00732094247053007320942470537320942470530732094247053

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
25
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094322866Welch Allyn, Inc.901134ESCRIBE-CAX-DXACB2019-07-22
00732094322873Welch Allyn, Inc.901134ESCRIBE-CAX-CXXXX2019-07-22
00732094322880Welch Allyn, Inc.901134ESCRIBE-CAX-CXACX2019-07-22
00732094322897Welch Allyn, Inc.901134ESCRIBE-CAX-CXACA2019-07-22
00732094322903Welch Allyn, Inc.901134ESCRIBE-BEX-CXXXA2019-07-22
00732094322910Welch Allyn, Inc.901134ESCRIBE-BEX-CXXCA2019-07-22
00732094322927Welch Allyn, Inc.901134ESCRIBE-BEX-CXACA2019-07-22
00732094322934Welch Allyn, Inc.901134ESCRIBE-BEX-CXAAA2019-07-22
00732094322941Welch Allyn, Inc.901134ESCRIBE-BAX-DXACX2019-07-22
00732094322958Welch Allyn, Inc.901134ESCRIBE-BAX-DXACB2019-07-22
00732094322965Welch Allyn, Inc.901134ESCRIBE-BAX-CXXXX2019-07-22
00732094322972Welch Allyn, Inc.901134ESCRIBE-BAX-CXACB2019-07-22
00732094322989Welch Allyn, Inc.901134ESCRIBE-BAX-CXACA2019-07-22
00732094322996Welch Allyn, Inc.901134ESCRIBE-BAX-CXAAX2019-07-22
00732094323009Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXX2019-07-22
00732094323016Welch Allyn, Inc.901134ESCRIBE-AEX-CXXXA2019-07-22
00732094323023Welch Allyn, Inc.901134ESCRIBE-AEX-CXAXA2019-07-22
00732094323030Welch Allyn, Inc.901134ESCRIBE-AEX-CXAAA2019-07-22
00732094323047Welch Allyn, Inc.901134ESCRIBE-AAX-DXXXX2019-07-22
00732094323054Welch Allyn, Inc.901134ESCRIBE-AAX-CXXXX2019-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094072709Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073362Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073621Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073683Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073898Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094074109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094136715Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136722Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136760Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094174021Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00304040090664Henry ScheinHENRY SCHEIN, INC.GCW2021-04-23
00732094342055Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342079Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342130Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342154Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342031Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342048Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342062Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342093Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342116Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342123Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342147Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342161Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342178Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342185Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094341805Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10
00732094341812Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10