AccessGUDID - DEVICE: Midmark (00841709118135)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark
Version or Model: M11-040 / 9A599001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M11-040-P
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709118135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The M11 Steam Sterilizer 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. The Midmark printer is designed to record and print sterilization cycle data including time, chamber temperature, and pressure.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38671	Steam sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	Active	false
38450	Ink printer	A colour or monochrome printer designed to propel droplets of ink directly onto a medium (typically paper) to produce a printed image.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLE	Sterilizer, steam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163337	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe07f18c-dbb1-4af0-817e-b8ac511969c1
Public Version Date: August 05, 2020
Public Version Number: 1
DI Record Publish Date: July 28, 2020