CURE ACP

GUDID B167700436000

MEDITECH SPINE, LLC

Bone tap, reusable
Primary Device IDB167700436000
NIH Device Record Key3207089e-bdda-4c3e-b443-f5526d7b83e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE ACP
Version Model Number700-436-00
Company DUNS182698477
Company NameMEDITECH SPINE, LLC
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 Numbertrue
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
HIBCCB167700436000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


[B167700436000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-30

On-Brand Devices [CURE ACP]

B167S1700435100S1-700-435-10
B167S1700430200S1-700-430-20
B167S1700430180S1-700-430-18
B167S1700430160S1-700-430-16
B167S1700430140S1-700-430-14
B167S1700430120S1-700-430-12
B167S1700430100S1-700-430-10
B167900430600900-430-60
B167900430550900-430-55
B167900430500900-430-50
B167900430450900-430-45
B167900430400900-430-40
B167900430350900-430-35
B167900430300900-430-30
B167900430250900-430-25
B167900430200900-430-20
B167700455000700-455-00
B167700436000700-436-00
B167700435100700-435-10
B167700430200700-430-20
B167700430180700-430-18
B167700430160700-430-16
B167700430140700-430-14
B167700430120700-430-12
B167700430100700-430-10

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