AccessGUDID - DEVICE: PULSAVAC® (00889024375109)

GUDID

Device Identifier (DI) Information

Brand Name: PULSAVAC®
Version or Model: 00-5150-350-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-5150-350-08
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024375109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: Power Supply, IN/ZA

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?
47893	Surgical/orthopaedic lavage system power supply	A dedicated mains electricity (AC-powered) device designed to convert mains current into the voltage required by a line-powered surgical lavage kit handpiece, to drive its integral pump during surgery to provide a pulsatile jet of sterile fluid (typically saline) to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET

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: bcbaf11f-8f3d-4770-a534-8e616bd6b057
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 01, 2016