OTSC System Set
- Primary DI
- 04260206310105
- Brand
- OTSC System Set
- Company
- Ovesco Endoscopy AG
- Model
- 12/6 t
- Catalog number
- 100.12
- Device description
- The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • 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
- Published
- 2015-09-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K101428 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260206310105 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260206310105 | 04260206310105 | 4260206310105 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +49707196528160 | service@ovesco.com |
| +19196519449 | customerservice@ovesco-usa.com |
Regulatory Flags#
- DUNS number
- 344007369
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04260206311966 | BougieCap P | P | 400.40 | 2026-01-16 |
| 04260206311911 | AWCduo | 124 cm | 200.57.05 | 2025-06-05 |
| 04260206311935 | AWCduo | 184 cm | 200.57.06 | 2025-06-05 |
| 04260206310983 | BARS Set | BARS Set | 100.60 | 2024-11-29 |
| 04260206310648 | Traction Polypectomy Snare | 220 cm | 200.55.10 | 2016-09-16 |
| 04260206311010 | colonic FTRD Set | 14 | 200.70 | 2018-05-28 |
| 04260206311027 | Coag Dissector | 165 cm | 200.50 | 2018-07-05 |
| 04260206311034 | AqaNife | 1.5 mm | 200.53.01 | 2018-10-02 |
| 04260206311041 | AqaNife | 2.0 mm | 200.53.02 | 2018-10-02 |
| 04260206311058 | AqaNife | 2.5 mm | 200.53.03 | 2018-10-02 |
| 04260206311065 | AqaNife | 3.0 mm | 200.53.04 | 2018-10-02 |
| 04260206311072 | diagnostic FTRD Set | 13 | 200.76 | 2018-10-02 |
| 04260206311003 | LiftUp | LiftUp | 200.56.01 | 2022-08-22 |
| 04260206311355 | LiftUp Kit | LiftUp Kit | 200.56.02 | 2022-08-22 |
| 04260206311263 | BARS Anchor silver | 165 cm | 200.12 | 2022-11-22 |
| 04260206311270 | BARS Anchor black | 165 cm | 200.13 | 2022-11-22 |
| 04260206310143 | OTSC Anchor | 165 cm | 200.10 | 2016-09-16 |
| 04260206310228 | OTSC Twin Grasper | 165 cm | 200.44 | 2016-09-16 |
| 04260206310235 | OTSC Twin Grasper | 220 cm | 200.45 | 2016-09-16 |
| 04260206310273 | OTSC Proctology Anchor | 38 cm | 200.61 | 2016-09-16 |
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