PASS TULIP

GUDID 03613720272809

OPEN ILIAC CONNECTOR - 100 mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID03613720272809
NIH Device Record Key7426cde8-97de-4429-9258-9064a6408674
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS TULIP
Version Model NumberB22066010
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
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 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
GS103613720272809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


[03613720272809]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-05-23
Device Publish Date2018-11-07

On-Brand Devices [PASS TULIP]

03613720274469SCREW REMOVER
03613720272830OPEN/OPEN DOMINO - 12 mm
0361372027470425mm reducer, long
03613720274667CLOSED ILIAC CONNECTOR - 50 mm
03613720274650CLOSED ILIAC CONNECTOR - 25 mm
03613720274643OPEN ILIAC CONNECTOR - 50 mm
03613720274636OPEN ILIAC CONNECTOR - 25 mm
03613720273011CLOSED ILIAC CONNECTOR - 60 mm
03613720273004OPEN ILIAC CONNECTOR - 60 mm
03613720272885CLOSED/CLOSED DOMINO - 12 mm
03613720272878CLOSED/CLOSED DOMINO - 17 mm
03613720272861OPEN/CLOSED DOMINO - 17 mm
03613720272854OPEN/CLOSED DOMINO - 12 mm
03613720272847OPEN/OPEN DOMINO - 17 mm
03613720272823CLOSED ILIAC CONNECTOR - 30 mm
03613720272816CLOSED ILIAC CONNECTOR - 100 mm
03613720272809OPEN ILIAC CONNECTOR - 100 mm
03613720272793OPEN ILIAC CONNECTOR - 30 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.