FDA UDI
In Commercial Distribution
🇺🇸 United States
BARS Anchor silver
DI: 04260206311263
·
Model: 165 cm
·
Ovesco Endoscopy AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BARS Anchor silver
- Primary DI
- 04260206311263
- Version / Model
- 165 cm
- Catalog Number
- 200.12
- Company Name
- Ovesco Endoscopy AG
- Labeler DUNS
- 344007369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 1
- Public Version Date
- 2022-11-30
- Public Version Status
- New
- Public Device Record Key
- 15071b28-e652-40a4-a8b3-e8a2b17110bf
Device Description
The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conjunction with the BARS Set. The BARS Anchor is available in two colours for better differentiation when using several instruments: spiral slotted tube in silver (BARS Anchor silver - 200.12) or in black (BARS Anchor black - 200.13). The Anchor needles are made of Nitinol.
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
- Yes
- 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 |
|---|---|---|---|---|
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33199 | Flexible endoscopic tissue manipulation forceps, single-use | A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260206311263 | GS1 |
Customer Contacts
- Phone
- +49707196528160
- [email protected]
- Phone
- +19196519449
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | working length 165 cm | ||
| Device Size Text, specify | working channel diameter 2.8 mm (standalone) | ||
| Device Size Text, specify | needle width 9 mm |