FDA.reportPublic FDA data

Tiger Medical Products

Primary DI
10840216101439
Brand
Tiger Medical Products
Company
Tiger Medical Group
Model
IVT501
Device description
Vaginal Speculum Disposable, Small, White
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20840216101436PackageGS14In Commercial Distribution
10840216101439PrimaryGS10
00840216101432Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084021610143620840216101436
1084021610143910840216101439
00840216101432008402161014328402161014320840216101432

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
404-696-6999diana.rogers@aspglobal.com

Regulatory Flags#

DUNS number
420944524
Device count
25
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840216101330Tiger Medical ProductsTTT8012016-10-01
20840216101337Tiger Medical ProductsTTT8012016-10-01
10840216101392Tiger Medical ProductsFMT5052016-10-01
10840216101408Tiger Medical ProductsFMT5082016-10-01
10840216101415Tiger Medical ProductsFMT5102016-10-01
10840216101422Tiger Medical ProductsFMT5172016-10-01
10840216101385Tiger Medical ProductsFMT5042016-10-01
20840216101399Tiger Medical ProductsFMT5052016-10-01
20840216101405Tiger Medical ProductsFMT5082016-10-01
20840216101412Tiger Medical ProductsFMT5102016-10-01
20840216101429Tiger Medical ProductsFMT5172016-10-01
00840216101487Tiger Medical ProductsUYT4122016-10-01
00840216101470Tiger Medical ProductsUYT4022016-10-01
10840216101347Tiger Medical ProductsOTT4032016-10-01
10840216101446Tiger Medical ProductsIVT5022016-10-01
10840216101460Tiger Medical ProductsTTT801B2016-10-01
00840216101456Tiger Medical ProductsORT400-BULK2016-10-01
10840216101453Tiger Medical ProductsORT400-BULK2016-10-01
10840216101484Tiger Medical ProductsUYT4122016-10-01

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