AccessGUDID - DEVICE: OTSC Proctology (04260206310266)

GUDID

Device Identifier (DI) Information

Brand Name: OTSC Proctology
Version or Model: 14 t
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.60
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 178b8bca-9750-4d93-94bd-febc83f3da10
Public Version Date: October 31, 2019
Public Version Number: 4
DI Record Publish Date: October 12, 2015