FDA UDI
In Commercial Distribution
🇺🇸 United States
AtriCure Isolator Synergy EnCompass Clamp and Guide System
DI: 10840143905995
·
Model: OSH
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- AtriCure Isolator Synergy EnCompass Clamp and Guide System
- Primary DI
- 10840143905995
- Version / Model
- OSH
- Catalog Number
- A001144SB
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 2
- Public Version Date
- 2023-02-23
- Public Version Status
- Update
- Public Device Record Key
- cc98f514-d9df-4902-bf35-c4e71e8d6c8c
Device Description
Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60784 | Cardiac radio-frequency ablation system generator | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840143904817 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 10840143905995 | GS1 | ||||
| Package | 50840143904071 | GS1 | case | 4 | In Commercial Distribution | |
| Previous | 10840143905209 | GS1 |
Customer Contacts
- Phone
- 866-449-2342
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity