DEVICE: OTSC Proctology (04260206310266)
Device Identifier (DI) Information
OTSC Proctology
14 t
In Commercial Distribution
200.60
Ovesco Endoscopy AG
14 t
In Commercial Distribution
200.60
Ovesco Endoscopy AG
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
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
59874 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PKL | Hemostatic Metal Clip For The Gi Tract |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150067 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: clip Type "t" has pointed teeth |
Device Record Status
178b8bca-9750-4d93-94bd-febc83f3da10
October 31, 2019
4
October 12, 2015
October 31, 2019
4
October 12, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49707196528160
service@ovesco.com +19196519449
customerservice@ovesco-usa.com
service@ovesco.com +19196519449
customerservice@ovesco-usa.com