AccessGUDID - DEVICE: Guidance (00887517170675)

GUDID

Device Identifier (DI) Information

Brand Name: Guidance
Version or Model: 2039901
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nuvasive, Inc.

Primary DI Number: 00887517170675
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053950783 *Terms of Use

Device Description: NVM5 Guidance Clip, Integrated

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?
46566	Neurophysiologic monitoring system	An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKN	Electromyograph, diagnostic
OLO	Orthopedic stereotaxic instrument
ETN	STIMULATOR, NERVE
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE
PDQ	Neurosurgical nerve locator
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143641	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 874e9d08-97cd-4718-8b3e-2cd3e0281fb9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(858)909-1800
Email: RA_UDI@nuvasive.com

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