AccessGUDID - DEVICE: V. Mueller (10885403115097)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: RH4330
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RH4330
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403115097
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 SHAMBAUGH REVERSE ADENOTOME LARGE SIZE 22 MM BLADE OVERALL LENGTH 9-1/8" (23.1CM)

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?
10025	Adenotome	A hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBH	ADENOTOME

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: 9f2a8df0-f8c6-49e9-a704-69eb1c14d698
Public Version Date: March 07, 2022
Public Version Number: 2
DI Record Publish Date: September 14, 2018