FDA.report

McKesson

Primary DI
40612479255409
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
200-C/A
Device description
Disposable Vag Specs
Published
2020-03-05
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

Related Records

Product Codes

CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications

CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612479255409PackageGS14In Commercial Distribution
20612479255399PrimaryGS10
10612479255385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061247925540940612479255409
2061247925539920612479255399
1061247925538510612479255385

GMDN Terms

TermDefinition
Vaginal speculum, single-useA 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 typically 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
40199536930009BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
40199536930016BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
40199536930023BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
40199536930030BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
40199536930047BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
40199536930054BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
05010058191457UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058191471UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058191495UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058191532UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058191570UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058191426UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-05-21
06972903330017SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903330021SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903330038SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331110SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331127SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331134SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331219SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331226SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903331233SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903332216SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903332223SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903332230SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333114SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333121SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333138SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333213SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333220SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
16972903333237SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11