FDA UDI In Commercial Distribution 🇺🇸 United States

Monoart

DI: E307229310080 · Model: MONOART EM21 · EURONDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Monoart
Primary DI
E307229310080
Version / Model
MONOART EM21
Catalog Number
22931008
Company Name
EURONDA SPA
Labeler DUNS
428755441
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-06
Public Version
1
Public Version Date
2019-12-16
Public Version Status
New
Public Device Record Key
36901029-7f26-47ed-b487-d3a3d43944b1

Device Description

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: green

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEA Cannula, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
38759 Dental suction system cannula, reusable

Identifiers

Type ID
Package E307229310082
Package E307229310081
Primary E307229310080