AccessGUDID - DEVICE: Orbit-Snare (04052838015387)

GUDID

Device Identifier (DI) Information

Brand Name: Orbit-Snare
Version or Model: 01-15-230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-15-230
Company Name: Medi-Globe GmbH

Primary DI Number: 04052838015387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318130267 *Terms of Use

Device Description: Orbit-Snare, Rotatable Polypectomy Snare Oval, Loop Diameter 15 mm, Catheter Diameter 2.5 mm, Sheath Length 230 cm

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":	No
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?
35622	Flexible polypectomy snare, single-use	A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FDI	Snare, Flexible

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and avoid exposure to sunlight and chemical fumes
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c4d2ec5-8e5d-4f71-b505-3fef60f4771b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016