AccessGUDID - DEVICE: V. Mueller (10885403010620)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU13720
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU13720
Company Name: STERIS CORPORATION

Primary DI Number: 10885403010620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller HOUSE-PAPARELLA STAPES CURETTE NO 19,DOUBLE-ENDED withVAL CUPS 2 X 3.3MM and 1.6 X 2.5MM OVERALL LENGTH 6-1/4 inches 15.9CM

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?
47522	Endaural surgical curette, reusable	A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYG	CURETTE, EAR

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: 5667854a-2e96-4c47-a74a-c3c9549c0745
Public Version Date: August 15, 2024
Public Version Number: 6
DI Record Publish Date: July 13, 2018