AccessGUDID - DEVICE: remOVE FBR Set (04260206310785)

GUDID

Device Identifier (DI) Information

Brand Name: remOVE FBR Set
Version or Model: 12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400.05
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps | alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: for endoscope diameter 9.5 - 12 mm
Device Size Text, specify: working channel diameter 2.8 mm
Device Size Text, specify: working length 220 cm

Device Record Status

Public Device Record Key: ad673a45-404d-428a-9233-0e95e3faa4ff
Public Version Date: October 31, 2019
Public Version Number: 3
DI Record Publish Date: October 02, 2018