MD Vue Discectomy 60-SC-3000

GUDID 00840019918848

Paddles / Cutters (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019918848
• NIH Device Record Key: 15061391-ddf4-4770-af49-1afcf43607d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD Vue Discectomy
• Version Model Number: 60-SC-3000
• Catalog Number: 60-SC-3000
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019918848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019918848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [MD Vue Discectomy]

• 00840019918909: Implant Caddy - 22mm X 0° (Empty)
• 00840019918893: 0° Implant Case (Empty)
• 00840019918879: Implant Caddy - 22mm X 7° (Empty)
• 00840019918862: 7° Implant Case (Empty)
• 00840019918848: Paddles / Cutters (Empty)
• 00840019918824: Cobbs / Curettes Case (Empty)
• 00840019918817: Trial 18 x 16 mm 7°
• 00840019918794: 60-TS-7812
• 00840019918787: Trial 18 x 10 mm 7°
• 00840019918756: Trial 22 x 14 mm 7°
• 00840019918732: Trial 22 x 10 mm 7°
• 00840019918718: Trial 18 x 16 mm 0°
• 00840019918688: Trial 18 x 10 mm 0°
• 00840019918671: Trial 18 x 08 mm 0°
• 00840019918664: Trial 22 x 16 mm 0°
• 00840019918657: Trial 22 x 14 mm 0°
• 00840019918640: Trial 22 x 12 mm 0°
• 00840019918633: Trial 22 x 10 mm 0°
• 00840019918626: Trial 22 x 08 mm 0°
• 00840019918619: 60-TA-7816
• 00840019918602: Angled Trials 18 X 14mm 7°
• 00840019918596: Angled Trials 18 X 12mm 7°
• 00840019918565: Angled Trials 22 X 16mm 7°
• 00840019918558: Angled Trials 22 X 14mm 7°
• 00840019918541: Angled Trials 22 X 12mm 7°
• 00840019918527: Angled Trials 22 X 08mm 7°
• 00840019918510: Slide
• 00840019918503: Slap Hammer
• 00840019918497: Rasp - 6mm
• 00840019918480: Pituitary Rongeur - 6 x 330mm
• 00840019918473: Pituitary Rongeur - 4 x 330mm
• 00840019918466: Kerrison Punch 40°- 6 x 330mm
• 00840019918459: Kerrison Punch 40°- 4 x 330mm
• 00840019918442: Angled Trial Rasp 18 x 16 mm 7°, R UP
• 00840019918435: Angled Trial Rasp 18 x 14 mm 7°, R UP
• 00840019918404: Angled Trial Rasp 18 x 08 mm 7°, R UP
• 00840019918398: Angled Trial Rasp 18 x 16 mm 0°
• 00840019918374: Angled Trial Rasp 18 x 12 mm 0°
• 00840019918367: Angled Trial Rasp 18 x 10 mm 0°
• 00840019918350: Angled Trial Rasp 18 x 08 mm 0°
• 00840019918343: Trial Rasp 18 x 16 mm 7°
• 00840019918329: Trial Rasp 18 x 12 mm 7°
• 00840019918305: Trial Rasp 18 x 08 mm 7°
• 00840019918299: Trial Rasp 18 x 16 mm 0°
• 00840019918282: Trial Rasp 18 x 14 mm 0°
• 00840019918275: Trial Rasp 18 x 12 mm 0°
• 00840019918251: Trial Rasp 18 x 08 mm 0°
• 00840019918244: Angled Trial Rasp 22 x 16 mm 7°, R UP
• 00840019918237: Angled Trial Rasp 22 x 14 mm 7°, R UP
• 00840019918220: Angled Trial Rasp 22 x 12 mm 7°, R UP