CURE ACP

GUDID B167700430100

MEDITECH SPINE, LLC

Fluted surgical drill bit, single-use, non-sterile
Primary Device IDB167700430100
NIH Device Record Key8722983a-18e3-42cf-afd1-89c6273b85cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE ACP
Version Model Number700-430-10
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
HIBCCB167700430100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B167700430100]

Moist Heat or Steam Sterilization


[B167700430100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2017-10-10

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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