FDA UDI In Commercial Distribution 🇺🇸 United States

Firefly

DI: 00886874112779 · Model: 950156 · INTUITIVE SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Firefly
Primary DI
00886874112779
Version / Model
950156
Company Name
INTUITIVE SURGICAL, INC.
Labeler DUNS
938647021
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-08
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
9fa664b2-4aff-41db-afe2-15ccb77d4a09

Device Description

FLUORESCENCE IMAGING PROCEDURE KIT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NAY System,surgical,computer controlled instrument

GMDN Terms

Code Name
57883 Surgical microscope fluorescent angiography system

Identifiers

Type ID
Package 10886874112776
Primary 00886874112779