AccessGUDID - DEVICE: V. Mueller (10885403034992)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: CH8320
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CH8320
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403034992
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller NEW ORLEANS ENDARTERECTOMY STRIPPER SET SIZES 4, 5, 6, 7 AND 9MM ON 12" (30.5CM) HANDLE

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?
31729	Intraluminal artery stripper, reusable	A hand-held manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including the "MollRing cutter". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWX	STRIPPER, ARTERY, INTRALUMINAL

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: e0a31062-5cc6-4e73-abf6-9ee652f0230f
Public Version Date: March 04, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016