AccessGUDID - DEVICE: V. Mueller (10885403114113)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: RH2400
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RH2400
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403114113
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: VAN STRUYCKEN NASAL CUTTING FORCEPS ALLIGATOR TYPE WORKING LENGTH 5"(12.7CM)

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?
33442	Craniofacial rongeur, reusable	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAE	FORCEPS, 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: a22d30a6-5a34-4a4e-8925-fe88e8548a23
Public Version Date: July 12, 2019
Public Version Number: 3
DI Record Publish Date: September 10, 2018