Model: OSL2
Catalog: A000432-12
DI: 10840143913761
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Isolator Synergy Clamp, Short Jaw, Left Curve
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
875b24b0-615b-4664-bc3e-4dd92c0b42fe
Distribution Status:
In Commercial Distribution
DUNS Number:
006133784
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
30840143909218
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840143913761
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840143913761
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
50840143909212
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
6
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30840143909218
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 60784
Name: Cardiac radio-frequency ablation system generator
Definition:
An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.
FDA Product Codes
OCM
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Premarket Submissions
Submission Number:
P100046
Supplement Number:
019