AccessGUDID - DEVICE: V. Mueller (10885403187988)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: NL4291-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NL4291-04
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403187988
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: MICRO HANDLE TAKE APART KERRISON RONGEUR, NON-COATED 40DEG UP, 4MM BITE, 10MM OPENING SHAFT LENGTH 10" (25.4CM)

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?
35541	Spinal rongeur	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAE	RONGEUR, MANUAL

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: 4fbfe45e-ed87-46ee-9a44-4ab2ed57d3e9
Public Version Date: February 27, 2020
Public Version Number: 2
DI Record Publish Date: August 10, 2018