FDA.reportPublic FDA data

ESI GloSpec

Primary DI
B3961403100
Brand
ESI GloSpec
Company
FTT MEDICAL, INC.
Model
140310
Catalog number
14-0310
Device description
Single use vaginal speculum with built in light source size small
Published
2019-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
B3961403101PackageHIBCC25In Commercial Distribution
B3961403102PackageHIBCC100In Commercial Distribution
B3961403100PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
002212793
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B39615001700ESI15-001702016-09-16
B3961501500ESI15-01502016-09-16
B3961501520ESI15-01522016-09-16
B3961501540ESI15-01542016-09-16
B3961501580ESI15-01582016-09-16
B3961501590ESI15-01592016-09-16
B3961501710ESI15-01712016-09-16
B3961501720ESI15-01722016-09-16
B396150172O0ESI15-0172-O2016-09-16
B3961501730ESI15-01732016-09-16
B3961501740ESI15-01742016-09-16
B3961501750ESI15-01752016-09-16
B3961501800ESI15-01802016-09-16
B3961501820ESI15-01822016-09-16
B3961501840ESI15-01842016-09-16
B3961501900ESI15-01902016-09-16
B3961501920ESI15-01922016-09-16
B3961501940ESI15-01942016-09-16
B3961501980ESI15-01982016-09-16
B3961502700ESI15-02702016-09-16

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