AccessGUDID - DEVICE: V. Mueller (10885403155611)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 89-2002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89-2002
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403155611
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: MICRO DIAMOND-TOUCH MAYFIELD GRASPER, TOOTH 20CM (8"), 3MM SHAFT DIAMETER

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?
38661	Rigid endoscopic grasping forceps, reusable	A rigid hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument; it is not an electrosurgical instrument. It is typically made of high-grade stainless steel and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FBM	Cannula and trocar, suprapubic, non-disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960400	000

Device Exempt from Premarket Submission: No 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: 72e86bd3-5a82-4a10-948b-852fbed4bfe5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016