FDA.reportPublic FDA data

Medichoice

Primary DI
10885632101410
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
VAG1003
Device description
Speculum Vaginal Large Disposable Clear Not Made With Natural Rubber Latex MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K050887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050887000GONGDONG DISPOSABLE VAGINAL SPECULUMZhejiang Gongdong Medical Plastic Factory2005-07-11HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885632101414PackageGS110In Commercial Distribution
50885632101418PackageGS110In Commercial Distribution
10885632101410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088563210141430885632101414
5088563210141850885632101418
1088563210141010885632101410

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

Regulatory Flags#

DUNS number
007941230
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524950SurgiTrackSM450087F0132026-07-10
10885632526978SurgiTrackSM450087C13B2026-07-10
10885632526992SurgiTrackSM4500415EEA2026-07-10
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632524790SurgiTrackSM450087D8CD2026-06-25
10885632524721SurgiTrackSM450070DAF72026-06-24
10885632524738SurgiTrackSM450071932C2026-06-24
10885632523267SurgiTrackSM45008746332026-06-10
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29
10860008900347ClearSpecClearspec LLCHIB2025-10-29
10860008900354ClearSpecClearspec LLCHIB2025-10-29
00860008900302ClearSpecClearspec LLCHIB2025-10-29
00860008900319ClearSpecClearspec LLCHIB2025-10-29
00860008900326ClearSpecClearspec LLCHIB2025-10-29
00860008900333ClearSpecClearspec LLCHIB2025-10-29
00860008900340ClearSpecClearspec LLCHIB2025-10-29
00860008900357ClearSpecClearspec LLCHIB2025-10-29
00199536930001BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930018BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930025BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930032BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930049BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930056BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
05010058091450UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091474UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091498UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091535UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091573UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091429UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-05-21
06972903330024SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
06972903330031SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11