AccessGUDID - DEVICE: Canaveral® (B183173000070)

GUDID

Device Identifier (DI) Information

Brand Name: Canaveral®
Version or Model: Canaveral®
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-7000-007
Company Name: FLOSPINE LLC

Primary DI Number: B183173000070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042993143 *Terms of Use

Device Description: Nav Screw Tap, 10.5mm

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic feeler	A hand-held manual surgical instrument designed to identify the position and/or shape of bone structures and/or cavities created within these structures, e.g., the angle of a drilled hole, during surgery. It is typically designed as a long, thin, shaft with a handle or handle connector at the proximal end and typically a round ball-tip at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to recognize structures and cavities through a tactile feedback. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic feeler

A hand-held manual surgical instrument designed to identify the position and/or shape of bone structures and/or cavities created within these structures, e.g., the angle of a drilled hole, during surgery. It is typically designed as a long, thin, shaft with a handle or handle connector at the proximal end and typically a round ball-tip at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to recognize structures and cavities through a tactile feedback. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
KWP	Appliance, Fixation, Spinal Interlaminal
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141850	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc3558e4-018d-4b6a-9a59-464203252e56
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 30, 2016