DEVICE: Guidance (00887517170620)

Device Identifier (DI) Information

Guidance
2030002
In Commercial Distribution

Nuvasive, Inc.
00887517170620
GS1

1
053950783 *Terms of Use
NVM5 Guidance Clip
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Orthopaedic stereotactic surgery system An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143641 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

62c9b5b4-b106-4644-a4f7-1101a1539f0d
July 06, 2018
3
September 26, 2016
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(858)909-1800
RA_UDI@nuvasive.com
CLOSE