IMPIX 3D Print B242C09123310

GUDID 03613720284574

IB3D TB (C) 09 x 12° x 33 x 10

MEDICREA INTERNATIONAL

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID03613720284574
NIH Device Record Keya2494186-8e5b-46a0-8dc7-99d14ea36555
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPIX 3D Print
Version Model NumberB242C09123310
Catalog NumberB242C09123310
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 Datetrue
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
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]
GS103613720284574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [IMPIX 3D Print]

03613720281627Implant remover
03613720271635Cage retriever
03613720267621TLIF-O Holder, Long
03613720267614TLIF-O Holder, Short
03613720267607TLIF-B Holder, Long
03613720267911Teardrop Curette, Angled
03613720267904Teardrop Curette, Straight
03613720267898Cup Curette, Straight #2 Serrated
03613720267881Cup Curette, Straight #2
03613720267874Cup Curette, Angled Up #4 Serrated
03613720267867Cup Curette, Angled Right #4 Serrated
03613720267850Cup Curette, Angled Left #4 Serrated
03613720267836Cup Curette, Straight #4 Serrated
03613720267829Cup Curette, Angled Up #4
03613720267812Cup Curette, Angled Right #4
03613720267805Cup Curette, Angled Left #4
03613720267782Cup Curette, Straight #4
03613720273226IB3D TB (E) 13 x 06° x 28 x 10 mm
03613720273202IB3D TB (E) 12 x 06° x 28 x 10 mm
03613720273189IB3D TB (E) 11 x 06° x 28 x 10 mm
03613720273165IB3D TB (E) 10 x 06° x 28 x 10 mm
03613720273141IB3D TB (E) 09 x 06° x 28 x 10 mm
03613720273127IB3D TB (E) 08 x 06° x 28 x 10 mm
03613720272786IB3D TO (C) 07 x 06° x 32 x 10
03613720272779IB3D TO (C) 07 x 06° x 28 x 10
03613720272762IB3D TO (C) 07 x 06° x 24 x 10
03613720272755IB3D TO (C) 15 x 06° x 32 x 10
03613720272748IB3D TO (C) 15 x 06° x 28 x 10
03613720272731IB3D TO (C) 15 x 06° x 24 x 10
03613720272724IB3D TO (C) 14 x 06° x 32 x 10
03613720272717IB3D TO (C) 14 x 06° x 28 x 10
03613720272700IB3D TO (C) 14 x 06° x 24 x 10
03613720272694IB3D TO (C) 13 x 06° x 32 x 10
03613720272687IB3D TO (C) 13 x 06° x 28 x 10
03613720272670IB3D TO (C) 13 x 06° x 24 x 10
03613720272663IB3D TO (C) 12 x 06° x 32 x 10
03613720272656IB3D TO (C) 12 x 06° x 28 x 10
03613720272649IB3D TO (C) 12 x 06° x 24 x 10
03613720272632IB3D TO (C) 11 x 06° x 32 x 10
03613720272625IB3D TO (C) 11 x 06° x 28 x 10
03613720272618IB3D TO (C) 11 x 06° x 24 x 10
03613720272601IB3D TO (C) 10 x 06° x 32 x 10
03613720272595IB3D TO (C) 10 x 06° x 28 x 10
03613720272588IB3D TO (C) 10 x 06° x 24 x 10
03613720272571IB3D TO (C) 09 x 06° x 32 x 10
03613720272564IB3D TO (C) 09 x 06° x 28 x 10
03613720272557IB3D TO (C) 09 x 06° x 24 x 10
03613720272540IB3D TO (C) 08 x 06° x 32 x 10
03613720272533IB3D TO (C) 08 x 06° x 24 x 10
03613720272526IB3D TO (C) 08 x 06° x 28 x 10

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