AccessGUDID - DEVICE: V. Mueller (10885403203893)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: OS5212-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OS5212-002
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403203893
Issuing Agency: GS1
Commercial Distribution End Date: January 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: SMILLIE KNIFE CURVED LEFT OVERALL LENGTH 6-3/4" (17.1CM)

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?
35138	Meniscus knife	A surgical instrument designed to apply pressure to and/or cut the crescent-shaped disk of fibrocartilage that borders and partly covers the articulating surfaces of the tibia and femur at the knee (meniscus). At the proximal end is a handle, sometimes T-shaped (Smillie design), that tapers to a cutting blade at the distal end. The blade is available in various designs (e.g., straight, curved, single- or double-edged) and may enable a chisel-like cutting action. The device is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDN	KNIFE, AMPUTATION

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: 7c99bce5-19da-4ff6-8900-257c409a1db9
Public Version Date: December 11, 2019
Public Version Number: 2
DI Record Publish Date: September 10, 2018