Aspirex Plus 04-0060-000

GUDID 10889981129880

8Ga x 6" Aspirex Plus

SEASPINE ORTHOPEDICS CORPORATION

Biopsy punch, reusable
Primary Device ID10889981129880
NIH Device Record Keyd4efd120-312c-4ac7-a0cf-2914fc9d34a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAspirex Plus
Version Model Number04-0060-000
Catalog Number04-0060-000
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981129880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-21
Device Publish Date2016-09-02

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