AccessGUDID - DEVICE: CONFIDENCE SPINAL CEMENT SYSTEM (10705034209555)

GUDID

Device Identifier (DI) Information

Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
Version or Model: 283905000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 283905000
Company Name: Medos International Sàrl

Primary DI Number: 10705034209555
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM 5cc

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45253	Orthopaedic cement preparation/delivery kit	A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDN	CEMENT, BONE, VERTEBROPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060300	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Flammable
Handling Environment Temperature: between 5 and 25 Degrees Celsius
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d47cc84f-4922-4a1c-b11d-104310ce8ff7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015