MYOSURE HYSTEROSCOPY SET

GUDID 25420045510323

Hologic, Inc.

Rigid optical hysteroscope
Primary Device ID25420045510323
NIH Device Record Keydce440e4-33ad-465a-86b6-69d272a3727c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMYOSURE HYSTEROSCOPY SET
Version Model Number40-250
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS125420045510323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


[25420045510323]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-10-03

On-Brand Devices [MYOSURE HYSTEROSCOPY SET]

2542004551032340-250
1542004551032640-250

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.