M11 Ultraclave M11-020R

GUDID 00841709100130

The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization

MIDMARK CORPORATION

Steam sterilizer
Primary Device ID00841709100130
NIH Device Record Key1fcdae92-bbda-4b74-a451-9b7feb94c343
Commercial Distribution StatusIn Commercial Distribution
Brand NameM11 Ultraclave
Version Model NumberM11-020R
Catalog NumberM11-020R
Company DUNS005036025
Company NameMIDMARK CORPORATION
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-(800)634-6288
Emailtelemarketing@midmark.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841709100130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [M11 Ultraclave]

00841709100130The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics, nursing homes,
00841709100116The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics, nursing homes,
00841709100109"The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes,

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