AccessGUDID - DEVICE: V. Mueller (10885403048111)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 88-5218
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 88-5218
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403048111
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: ENDOPLASTIC RETRACTOR 9/16" X 4 3/4" BLADE FOR 5MM SCOPE

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?
58096	Internally-anchored endoscopic retractor	A sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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: 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: b14b64b6-f751-4524-b26c-a21199c9bc70
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016