FDA UDI In Commercial Distribution 🇺🇸 United States

Saturn 5 Laser System

DI: 05060488044847 · Model: Saturn 5 Active 20x Nikon Ti2 with Nikon XY Stage · RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Saturn 5 Laser System
Primary DI
05060488044847
Version / Model
Saturn 5 Active 20x Nikon Ti2 with Nikon XY Stage
Catalog Number
6-47-500-28
Company Name
RESEARCH INSTRUMENTS LIMITED
Labeler DUNS
536139413
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-23
Public Version
4
Public Version Date
2024-02-28
Public Version Status
Update
Public Device Record Key
dea8363f-80a0-4f4b-8ff0-f61703112abf

Device Description

Assisted Reproduction Laser

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
MRX System, assisted reproduction laser

GMDN Terms

Code Name
61181 Assisted reproduction laser system

Identifiers

Type ID
Primary 05060488044847

Customer Contacts

Phone
+4546790202

Premarket Submissions

Submission Number Supplement Number
K141434 000