AccessGUDID - DEVICE: V. Mueller (10885403035197)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: CH8585
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CH8585
Company Name: STERIS CORPORATION

Primary DI Number: 10885403035197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller JACOBSON ENDARTERECTOMY SPATULA, ANGLED 45DEG SEMI-SHARP BLADE 10X1MM WIDE OVERALL LENGTH 7 inches 17.8CM

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?
38127	Vascular spatula	A hand-held surgical instrument designed to be used within the vasculature (a blood vessel) to scrape, manipulate, and remove tissue therein. It typically made of high-grade stainless steel and consists of a flat blunt blade (no sharp edges) that is either single-ended or double-ended (a blade at either end). It is available with a variety of blade designs, e.g., curved and spoon-shaped or curved and straight. The handle can be placed proximally or be formed from its middle section and may be more prominent/serrated. 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: 70111d90-49f3-4279-ba50-1f9fe441ca1e
Public Version Date: August 16, 2024
Public Version Number: 4
DI Record Publish Date: August 17, 2018