AccessGUDID - DEVICE: Preference 2 (M555211000102)

GUDID

Device Identifier (DI) Information

Brand Name: Preference 2
Version or Model: C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21-1000-102
Company Name: AMEDICA CORPORATION

Primary DI Number: M555211000102
Issuing Agency: HIBCC
Commercial Distribution End Date: November 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 028629553 *Terms of Use

Device Description: Poly Screw Driver - HF

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?
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, Fixation, Spinal Intervertebral Body
KWP	Appliance, Fixation, Spinal Interlaminal
MNI	Orthosis, Spinal Pedicle Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36e429e1-1ada-45ac-bb20-9c930931a9c8
Public Version Date: November 21, 2024
Public Version Number: 5
DI Record Publish Date: December 29, 2017