N/A 53-Syringe-1

GUDID 00846468050542

Bone Graft Delivery System

Pioneer Surgical Technology, Inc.

Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit Bone graft delivery kit
Primary Device ID00846468050542
NIH Device Record Key3c645ef8-9902-4313-93ea-4f3343decca9
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number53-Syringe-1
Catalog Number53-Syringe-1
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468050542 [Primary]

FDA Product Code

EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-25

On-Brand Devices [N/A]

00846468060787Bipolar Forceps, Straight, 9.7", 0.4mm
00846468060527Bipolar Forceps, Bent, 9.7", Small
00846468060510Bipolar Forceps, Straight, 9.7", Small
00846468060466Bipolar Forceps, Bent, 9.7", 1.5mm Tip
00846468060435Bipolar Forceps, Bent, 9.7", 1.0mm Tip
00846468060404Bipolar Forceps, Bent, 9.7", 0.4mm Tip
00846468057572AUXILIARY CASE
00846468050542Bone Graft Delivery System
00846468049386Bipolar Forceps, Straight, 9.7", 1.5mm
00846468049287Bipolar Forceps, Straight, 9.7", Large
00846468049270Bipolar Forceps, Straight, 9.7", 1.0mm
00846468041052AWL
00846468041045HEX DRIVER, 3.5mm

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