AccessGUDID - DEVICE: V. Mueller (10885403133640)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: SU665-016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SU665-016
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403133640
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: FRANKFELDT RECTAL SNARE HINGED WIRE LOOP ONLY OVERALL LENGTH 16"(40.6CM)

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:	No
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?
62615	Mechanical-cutting endoscopic polypectomy snare	A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.	Active	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: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec0347e6-6a26-445a-bbb2-97424e5d7b8e
Public Version Date: August 21, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016