FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094236453
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901070
Catalog number
78950
Device description
KleenSpec Corded Illuminate System INTL
Published
2021-05-07
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
HIBSpeculum, vaginal, nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120743000SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.2012-03-23HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094236453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094236453007320942364537320942364530732094236453

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

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
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

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00860008900302ClearSpecClearspec LLCHIB2025-10-29
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00860008900326ClearSpecClearspec LLCHIB2025-10-29
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