AccessGUDID - DEVICE: V. Mueller (10885403035890)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: CH9210-003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CH9210003
Company Name: STERIS CORPORATION

Primary DI Number: 10885403035890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller MILLS CORONARY ENDARTERECTOMY SPATULA BLADE 1.2MM WIDE OVERALL LENGTH 6-1/2 inches 16.5CM

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?
17252	Endarterectomy loop puller	A hand-held manual surgical instrument designed to be used together with an endarterectomy loop (a special wire loop) that is inserted into the lumen of an artery to grip and shear atherosclerotic deposits (i.e., thickened atheromatous tunica intima) from the lumen of the artery (i.e., endarterectomy). This device is used to help the operator manually pull the loop through the main arteries of the body, e.g., the carotid artery. It usually includes a freely rotational handle to avoid the inducement of torsion forces upon the loop and may include a shear force gauge to limit the pulling force applied to the loop. It is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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: f752159c-99ac-4ac7-9338-0ebf90d70f25
Public Version Date: August 16, 2024
Public Version Number: 4
DI Record Publish Date: August 17, 2018