AccessGUDID - DEVICE: V. Mueller (10885403012495)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: AU19060
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU19060
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403012495
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 SCHUKNCHT SICKLE KNIFE 7MM SINGLE-EDGED BLADE ANGLED 17DEG OVERALL LENGTH 6-1/4" (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?
12245	Ear knife	A hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYL	HOOK, MICROSURGICAL 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: a76a6693-1b3a-4d39-9ce7-5195673a2741
Public Version Date: March 04, 2022
Public Version Number: 2
DI Record Publish Date: August 02, 2018