FDA UDI In Commercial Distribution 🇺🇸 United States

Dornier Thulio

DI: 04049958004551 · Model: K2016000 · Dornier MedTech GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dornier Thulio
Primary DI
04049958004551
Version / Model
K2016000
Catalog Number
K2016000
Company Name
Dornier MedTech GmbH
Labeler DUNS
388104085
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-27
Public Version
3
Public Version Date
2024-02-08
Public Version Status
Update
Public Device Record Key
fde54a17-79aa-4fa4-97bb-fb750f2966e8

Device Description

Dornier Thulio

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
No
PM Exempt
No
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
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
36170 General/multiple surgical solid-state laser system

Identifiers

Type ID
Primary 04049958004551