mini OTSC System Set
- Primary DI
- 04260206311522
- Brand
- mini OTSC System Set
- Company
- Ovesco Endoscopy Usa, Inc.
- Model
- mini/6 t
- Catalog number
- 100.02
- Device description
- The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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
- 2024-09-13
- 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 |
|---|---|---|---|---|
| 04260206311522 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260206311522 | 04260206311522 | 4260206311522 |
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 |
| 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 |
| 04260206311676 | OTSC System Set | 12/3 t - 220 | 100.29 | 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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