OTSC Proctology
- Primary DI
- 04260206310266
- Brand
- OTSC Proctology
- Company
- Ovesco Endoscopy AG
- Model
- 14 t
- Catalog number
- 200.60
- Device description
- OTSC Proctology is an innovative clipping system to be applied in proctology procedures • it is used for wall closure in the anorectum (e.g. fistulae) • offers three unique advantages: large volume of tissue secured high stability at the lesion site minimal strain on surrounding tissue • exceptional properties and therapeutic functions are based on its special design and material: superelastic Nitinol • material is biocompatible, can be applied as a long-term implant • absorbable U-shaped sutures or the OTSC Proctology Anchor may be used to place the applicator cap precisely on the lesion
- Published
- 2015-10-12
- 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 |
|---|---|
| K150067 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260206310266 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260206310266 | 04260206310266 | 4260206310266 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endoscopic manual linear stapler | A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| 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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