AccessGUDID - DEVICE: V. Mueller (10885403058646)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: MO1080
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MO1080
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403058646
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: TYDINGS TONSIL KNIFE OVERALL LENGTH 7-3/4" (19.6CM)

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?
12255	Tonsil knife	A hand-held manual surgical instrument intended for the removal of the tonsils during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, scythe-like, cutting blade at the distal end (the internal radius of the curve has the cutting edge) which is normally quite small; it has a very long and 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
KBQ	KNIFE, TONSIL

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: e5b65626-b017-475a-b3bc-92b952ef3108
Public Version Date: March 25, 2020
Public Version Number: 2
DI Record Publish Date: August 10, 2018