AccessGUDID - DEVICE: V. Mueller (10885403037061)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: E-0540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E0540
Company Name: STERIS CORPORATION

Primary DI Number: 10885403037061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller Neuro/Spine MURPHY BALL HOOK OVERALL LENGTH 90DEG BEND 8 inches 200MM

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?
35100	Extracorporeal bubble oxygenator	A device designed to perform gas exchange by bubbling oxygen from tanks or from a central hospital supply through a column of blood. It typically includes a defoamer to break up the bubbles caused by the oxygenation process, and an arterial reservoir that collects defoamed blood; a gas flowmeter and a filtering system are usually placed in the oxygen line. This oxygenator is mostly used in short-term procedures as lengthy operation of the device could increase the risk of gas emboli, blood damage, and protein denaturization. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

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: f1859c13-36b9-4d6b-bd1c-deee82e1a266
Public Version Date: August 19, 2024
Public Version Number: 4
DI Record Publish Date: August 17, 2018