FDA UDI
In Commercial Distribution
🇺🇸 United States
BARS Set
DI: 04260206310983
·
Model: BARS Set
·
Ovesco Endoscopy AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BARS Set
- Primary DI
- 04260206310983
- Version / Model
- BARS Set
- Catalog Number
- 100.60
- Company Name
- Ovesco Endoscopy AG
- Labeler DUNS
- 344007369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-29
- Public Version
- 1
- Public Version Date
- 2024-12-09
- Public Version Status
- New
- Public Device Record Key
- f52eb525-2137-4926-9e9c-0c3afc86d2b1
Device Description
The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260206310983 | GS1 |
Customer Contacts
- Phone
- +49707196528160
- [email protected]
- Phone
- +19196519449
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241858 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Length | 1800 | Millimeter | |
| Balloon Diameter | 20 | Millimeter | |
| Balloon Length | 1850 | Millimeter | |
| Balloon Diameter | 6 | Millimeter | |
| Guidewire Length | 3700 | Millimeter | |
| Guidewire Diameter | 0.035 | Inch | |
| Device Size Text, specify | for endoscopes with diameter of 10 - 12 mm | ||
| Device Size Text, specify | for endoscopes with a working length of 1030 - 1100 mm | ||
| Device Size Text, specify | for endoscopes with a working channel diameter of 3.7 mm |