FDA UDI
In Commercial Distribution
🇺🇸 United States
Barrx
DI: 10884521663503
·
Model: TTS-2100
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barrx
- Primary DI
- 10884521663503
- Version / Model
- TTS-2100
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-21
- Public Version
- 2
- Public Version Date
- 2023-02-08
- Public Version Status
- Update
- Public Device Record Key
- f50735ec-9120-4849-a156-c323b6074cda
Device Description
Barrx SB RFA Endoscopic Catheter
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66665 | Gastrointestinal radio-frequency ablation system catheter | A semi-flexible tubular device with a bipolar electrode(s) at its distal end intended to be endoscopically introduced into the gastrointestinal (GI) tract (e.g., oesophagus, stomach, rectum, anus) to deliver radio-frequency (RF) current from a connected RF generator (not included) for focal ablation of a GI lesion (e.g., neoplasm); it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a closed fluid circuit for cooling of the tip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521663503 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173559 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.75 | Millimeter | |
| Width | 7.5 | Millimeter |