OTSC System Set
- Primary DI
- 04260206311676
- Brand
- OTSC System Set
- Company
- Ovesco Endoscopy Usa, Inc.
- Model
- 12/3 t - 220
- Catalog number
- 100.29
- 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
- 2024-09-10
- Public version status
- New
- 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 |
|---|---|---|---|---|
| 04260206311676 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260206311676 | 04260206311676 | 4260206311676 |
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, 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. |
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 | |
|---|---|
| +19196519449 | customerservice@ovesco-usa.com |
Regulatory Flags#
- DUNS number
- 969139760
- 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 |
|---|---|---|---|---|
| 04260206311515 | mini OTSC System Set | mini/6 a | 100.01 | 2024-09-13 |
| 04260206311522 | mini OTSC System Set | mini/6 t | 100.02 | 2024-09-13 |
| 04260206311706 | stentfix OTSC System Set | stentfix | 100.50 | 2024-09-13 |
| 04260206311539 | OTSC System Set | 11/3 a | 100.03 | 2024-09-10 |
| 04260206311546 | OTSC System Set | 11/3 t | 100.04 | 2024-09-10 |
| 04260206311553 | OTSC System Set | 12/3 a | 100.05 | 2024-09-10 |
| 04260206311560 | OTSC System Set | 12/3 t | 100.06 | 2024-09-10 |
| 04260206311577 | OTSC System Set | 14/3 a | 100.07 | 2024-09-10 |
| 04260206311584 | OTSC System Set | 14/3 t | 100.08 | 2024-09-10 |
| 04260206311591 | OTSC System Set | 11/6 a | 100.09 | 2024-09-10 |
| 04260206311607 | OTSC System Set | 11/6 t | 100.10 | 2024-09-10 |
| 04260206311614 | OTSC System Set | 12/6 a | 100.11 | 2024-09-10 |
| 04260206311621 | OTSC System Set | 12/6 t | 100.12 | 2024-09-10 |
| 04260206311638 | OTSC System Set | 14/6 a | 100.13 | 2024-09-10 |
| 04260206311645 | OTSC System Set | 14/6 t | 100.14 | 2024-09-10 |
| 04260206311652 | OTSC System Set | 12/6 gc | 100.27 | 2024-09-10 |
| 04260206311669 | OTSC System Set | 12/3 a - 220 | 100.28 | 2024-09-10 |
| 04260206311683 | OTSC System Set | 12/6 a - 220 | 100.30 | 2024-09-10 |
| 04260206311690 | OTSC System Set | 12/6 t - 220 | 100.31 | 2024-09-10 |
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