30 Degree 3.7mm Diagnostic Sheath

GUDID 15420045513624

Hologic, Inc.

Rigid optical hysteroscope
Primary Device ID15420045513624
NIH Device Record Key02a84510-3ddd-4469-900b-f199c2a64346
Commercial Distribution StatusIn Commercial Distribution
Brand Name30 Degree 3.7mm Diagnostic Sheath
Version Model Number60-201-30
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 Kitfalse
Device Combination Productfalse
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
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
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
GS115420045513624 [Primary]
GS125420045513621 [Package]
Package: EACH [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

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[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

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[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

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[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


[15420045513624]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

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