FDA UDI In Commercial Distribution 🇺🇸 United States

EASYMIX® vacuum pump I

DI: 04260056881633 · Model: 02-0401 · OSARTIS GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EASYMIX® vacuum pump I
Primary DI
04260056881633
Version / Model
02-0401
Catalog Number
02-0401
Company Name
OSARTIS GmbH
Labeler DUNS
344261631
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-01
Public Version
1
Public Version Date
2022-12-09
Public Version Status
New
Public Device Record Key
7cee52b2-60e0-4526-9e8d-6059c61945e9

Device Description

The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JDY Evacuator, Vapor, Cement Monomer

GMDN Terms

Code Name
60520 Orthopaedic material preparation vacuum pump

Identifiers

Type ID
Primary 04260056881633