DEVICE: Bendini (00887517285287)

Device Identifier (DI) Information

Bendini
8210007
In Commercial Distribution

Nuvasive, Inc.
00887517285287
GS1

1
053950783 *Terms of Use
Bendini Guideless Pointer, Adjustable
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Spinal rod bending system An assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device.
CLOSE

FDA Product Code

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

FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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

f79f1457-78c2-4c71-b938-2a8b1d9f7412
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
No
No
No CLOSE

Customer Contact

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