NuVasive

GUDID 00887517949196

Limited Travel Shim Inserter

Nuvasive, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00887517949196
• NIH Device Record Key: 4f2675d1-0604-4d2d-9e36-55fb39f8db7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVasive
• Version Model Number: Z200184
• Company DUNS: 053950783
• Company Name: Nuvasive, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517949196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112709

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

[00887517949196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [NuVasive]

• 00887517533982: Universal Threaded Pin, Bone Mill
• 00887517498182: Universal Counter Torque
• 00887517488671: Universal Guide, Size 10 Bone Mill
• 00887517488657: Universal Guide, Size 6 Bone Mill
• 00887517451552: Universal Graft Pusher, Cervical Solid
• 00887517429209: Univ Pedicle Probe, Ball Tip Curved
• 00887517428998: Universal Probe, Ball-Tip
• 00887517405449: CoRoent XLR Driver, Detachable
• 00887517391339: CoRoent XLW Trial, 14x22x60mm 10°
• 00887517391322: CoRoent XLW Trial, 12x22x60mm 10°
• 00887517391315: CoRoent XLW Trial, 10x22x60mm 10°
• 00887517391308: CoRoent XLW Trial, 8x22x60mm 10°
• 00887517390974: CoRoent XLW Trial, 12x22x50mm 10°
• 00887517390967: CoRoent XLW Trial, 10x22x50mm 10°
• 00887517390950: CoRoent XLW Trial, 8x22x50mm 10°
• 00887517389091: Universal Inserter, XLIF Angled
• 00887517389084: Universal Tamp, XLIF Angled
• 00887517389077: Universal Rasp, Angled
• 00887517389053: Universal Currette, Angled Down Medium
• 00887517389046: Universal Currette, Angled Up Medium
• 00887517389039: Universal Cobb, Down Large
• 00887517389022: Universal Cobb, Up Large
• 00887517389015: Universal Cobb, Angled Down Small
• 00887517389008: Universal Cobb, Angled Up Small
• 00887517388698: Universal Rongeur, Angled Left Large
• 00887517388681: Universal Rongeur, Angled Right Large
• 00887517388674: Universal Rongeur, Med Angled Left
• 00887517388667: Universal Rongeur, Med Angled Right
• 00887517388650: Universal Broach 10x18mm Angled
• 00887517388643: Universal Broach 8x18mm Angled
• 00887517388636: Universal Broach 6x18mm Angled
• 00887517388209: Universal Trial 12x22x60mm CoRoent XLW
• 00887517387899: Universal Trial 10x22x60mm CoRoent XLW
• 00887517387882: Universal Trial 8x22x60mm CoRoent XLW
• 00887517387851: Universal Trial 12x22x50mm CoRoent XLW
• 00887517387844: Universal Trial 10x22x50mm CoRoent XLW
• 00887517387837: Universal Trial 8x22x50mm CoRoent XLW
• 00887517386595: Universal Guide, Drill
• 00887517386557: Universal Drill, 2.5mm Extractor
• 00887517386533: Universal Extractor, 4.5mm Tap
• 00887517386526: Universal Extractor, 3.5mm Tap
• 00887517386519: Universal Extractor, 2.5mm Tap
• 00887517385840: Universal Osteotome, 16 Straight
• 00887517385802: Universal Rongeur, Pituitary Small
• 00887517385536: Universal Rasp, Serrated Thoracic
• 00887517383068: Universal Disc Cutter, 6mm AL
• 00887517383020: Universal Rongeur, 2mm Kerrison
• 00887517382351: Universal Inserter, CoRoent XL
• 00887517381910: Universal Curette, 2mm Down Facing
• 00887517381903: Universal Curette, X-Small Up Angled