AccessGUDID - DEVICE: DISCOVERY TiNano ACIF (B521105010507)

GUDID

Device Identifier (DI) Information

Brand Name: DISCOVERY TiNano ACIF
Version or Model: 105010507
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 105010507
Company Name: AURORA SPINE, INC.

Primary DI Number: B521105010507
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079119091 *Terms of Use

Device Description: DISCOVERY TiNano ACIF 14mm X 16mm X 5 X 7

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:	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?
60841	Cardiopulmonary resuscitation feedback device, manual	A portable, manually-operated device intended to be applied to the chest of a patient experiencing cardiac arrest to assist a person trained in cardiopulmonary resuscitation (CPR) to deliver effective manual chest compressions. It typically consists of a chest plate with a large depressible button and is intended to translate an applied downward force into a well-positioned chest compression whilst indicating (e.g., with a click) when optimum force has been applied/removed; it may also assist the timing of chest compressions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111484	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 7 Millimeter
Angle: 5 degree
Width: 16 Millimeter
Length: 14 Millimeter

Device Record Status

Public Device Record Key: c7c624bf-b035-4b3a-bfeb-24a29a91b486
Public Version Date: February 04, 2019
Public Version Number: 5
DI Record Publish Date: February 02, 2017