AccessGUDID - DEVICE: nuMIS Lumbar Plating System (00841193103099)

GUDID

Device Identifier (DI) Information

Brand Name: nuMIS Lumbar Plating System
Version or Model: 27161
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 27161
Company Name: Cutting Edge Spine, LLC

Primary DI Number: 00841193103099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472647 *Terms of Use

Device Description: nuMIS™ Long Hex Driver

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):	No
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?
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051044	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

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 12 Inch

Device Record Status

Public Device Record Key: f113acce-72a5-4633-8475-f2b825aa46ac
Public Version Date: October 05, 2018
Public Version Number: 5
DI Record Publish Date: October 30, 2015