AccessGUDID - DEVICE: Mopec (00850020091003)

GUDID

Device Identifier (DI) Information

Brand Name: Mopec
Version or Model: 115V Autopsy Saw
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0810-MPC-000
Company Name: Contract Medical Manufacturing, Limited Liability Company

Primary DI Number: 00850020091003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868719191 *Terms of Use

Device Description: The CMM 115V Autopsy Saw is an FDA Class I product used for performing autopsies, featuring a high-speed oscillating blade to cut through cadaver bone without harming soft tissue.

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):	No
Kit:	No
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?
44142	Line-powered autopsy saw	A mains electricity (AC-powered) device that consists of motorized handpiece designed to hold and provide torque for a circular rotating blade used during an autopsy to cut through bone and tough tissues, especially for the removal of the upper part of the cranium. It may include an extraction unit with a container for collecting tissue/bone debris. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAB	Saw, Powered, And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 11a59b01-1c2b-4add-9fb7-50e88f5bc764
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023