MD Vue Discectomy 60-SC-5002

GUDID 00840019918886

Implant Caddy - 18mm X 7° (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019918886
NIH Device Record Keyf521b238-128f-428c-b9d6-7da8f8781332
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD Vue Discectomy
Version Model Number60-SC-5002
Catalog Number60-SC-5002
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019918886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019918886]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

On-Brand Devices [MD Vue Discectomy]

00840019918909Implant Caddy - 22mm X 0° (Empty)
008400199188930° Implant Case (Empty)
00840019918879Implant Caddy - 22mm X 7° (Empty)
008400199188627° Implant Case (Empty)
00840019918848Paddles / Cutters (Empty)
00840019918824Cobbs / Curettes Case (Empty)
00840019918817Trial 18 x 16 mm 7°
0084001991879460-TS-7812
00840019918787Trial 18 x 10 mm 7°
00840019918756Trial 22 x 14 mm 7°
00840019918732Trial 22 x 10 mm 7°
00840019918718Trial 18 x 16 mm 0°
00840019918688Trial 18 x 10 mm 0°
00840019918671Trial 18 x 08 mm 0°
00840019918664Trial 22 x 16 mm 0°
00840019918657Trial 22 x 14 mm 0°
00840019918640Trial 22 x 12 mm 0°
00840019918633Trial 22 x 10 mm 0°
00840019918626Trial 22 x 08 mm 0°
0084001991861960-TA-7816
00840019918602Angled Trials 18 X 14mm 7°
00840019918596Angled Trials 18 X 12mm 7°
00840019918565Angled Trials 22 X 16mm 7°
00840019918558Angled Trials 22 X 14mm 7°
00840019918541Angled Trials 22 X 12mm 7°
00840019918527Angled Trials 22 X 08mm 7°
00840019918510Slide
00840019918503Slap Hammer
00840019918497Rasp - 6mm
00840019918480Pituitary Rongeur - 6 x 330mm
00840019918473Pituitary Rongeur - 4 x 330mm
00840019918466Kerrison Punch 40°- 6 x 330mm
00840019918459Kerrison Punch 40°- 4 x 330mm
00840019918442Angled Trial Rasp 18 x  16 mm 7°, R UP
00840019918435Angled Trial Rasp 18 x  14 mm 7°, R UP
00840019918404Angled Trial Rasp 18 x  08 mm 7°, R UP
00840019918398Angled Trial Rasp 18 x 16 mm 0°
00840019918374Angled Trial Rasp 18 x 12 mm 0°
00840019918367Angled Trial Rasp 18 x 10 mm 0°
00840019918350Angled Trial Rasp 18 x 08 mm 0°
00840019918343Trial Rasp 18 x 16 mm 7°
00840019918329Trial Rasp 18 x 12 mm 7°
00840019918305Trial Rasp 18 x 08 mm 7°
00840019918299Trial Rasp 18 x 16 mm 0°
00840019918282Trial Rasp 18 x 14 mm 0°
00840019918275Trial Rasp 18 x 12 mm 0°
00840019918251Trial Rasp 18 x 08 mm 0°
00840019918244Angled Trial Rasp 22 x  16 mm 7°, R UP
00840019918237Angled Trial Rasp 22 x  14 mm 7°, R UP
00840019918220Angled Trial Rasp 22 x  12 mm 7°, R UP

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