FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094136098
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901073
Catalog number
88010
Device description
Cervical Model for Video Colposcope
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEXCOLPOSCOPE (AND COLPOMICROSCOPE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEXColposcope (And Colpomicroscope)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955635000VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STANDWelch Allyn, Inc.1996-05-07HEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094136098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094136098007320941360987320941360980732094136098

GMDN Terms#

Term, Definition table
TermDefinition
ColposcopeAn electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing.

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

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
B366U1C200AR01MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200WR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366HC200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-25
B366U1C200FR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200FR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
GYNX530LVCDAR0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530LVCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAR0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
05060477110263DYSIS ViewDYSIS MEDICAL LIMITEDHEX2023-12-01
B366MC400MICROSTAR ColposcopeEclerisHEX2023-08-22
B366MC410MICROSTAR ColposcopeEclerisHEX2023-08-22
B366C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C200TRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200WRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200ARX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200FRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B632MDB01039MedibluMedisono, LLCHEX2022-05-06
B632MDB01038MedibluMEDIBLU MEDICAL LLCHEX2020-12-28
B632MDB01036MedibluMEDIBLU MEDICAL LLCHEX2020-12-18
57290018240026Gynescope, console systemILLUMIGYN LTDHEX2020-11-26
67290018240016Gynescope Image acquistion systemILLUMIGYN LTDHEX2020-11-26