CURE ACP

GUDID B167S1700430120

MEDITECH SPINE, LLC

Fluted surgical drill bit, single-use, sterile
Primary Device IDB167S1700430120
NIH Device Record Key1edf79d1-c82d-48e2-85ca-e4688a0a73f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE ACP
Version Model NumberS1-700-430-12
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 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
HIBCCB167S1700430120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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