AccessGUDID - DEVICE: V. Mueller (10885403010026)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU12503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU12503
Company Name: STERIS CORPORATION

Primary DI Number: 10885403010026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: WIET-DERLACKI MODIFIED MOBILIZER, ANGLE, CONE-SHAPED SERRATED 1MM TIP OVERALL LENGTH 6-1/2 inches16.5CM

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?
33432	ENT mobilizer	A hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAJ	MOBILIZER, ENT

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: ce3202c8-bc28-4340-bd4b-517aed780492
Public Version Date: August 15, 2024
Public Version Number: 3
DI Record Publish Date: July 13, 2018