FDA UDI In Commercial Distribution 🇺🇸 United States

Rutilight

DI: 08437016917176 · Model: RL-01 · SWAN MEDICAL SL.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Rutilight
Primary DI
08437016917176
Version / Model
RL-01
Company Name
SWAN MEDICAL SL.
Labeler DUNS
467190738
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-31
Public Version
1
Public Version Date
2025-02-10
Public Version Status
New
Public Device Record Key
accdbb6c-1312-497d-aa80-b4497320cc89

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FSQ Light, Surgical, Instrument

GMDN Terms

Code Name
65349 Open surgical site internal light

Identifiers

Type ID
Primary 08437016917176

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
5 – 40 Degrees Celsius