AccessGUDID - DEVICE: NA (00889024374874)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 00-5049-086-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-5049-086-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024374874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: No description.

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):	Yes
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?
46482	Orthopaedic cement fume evacuator	A mains electricity (AC-powered) portable device designed to filter out and/or evacuate the toxic fumes produced during the preparation of orthopaedic cement [e.g., polymethylmethacrylate (PMMA)] before they can reach the environment. The device is a small enclosure with filters that remove the toxic vapors, diffusing the filtered air in the environment, or that may be connected to the hospital exhaustion system. This device is used mainly in operating rooms and other hospital areas during orthopaedic procedures that involve bone cement preparation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDY	EVACUATOR, VAPOR, CEMENT MONOMER

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a6cfbdd3-a741-4a03-b690-c161ce5f84e6
Public Version Date: February 23, 2021
Public Version Number: 2
DI Record Publish Date: March 08, 2019