Barricaid® ACD (Annular Closure Device) BAR-A8-8MM

GUDID M906BARA88MM0

Barricaid® Annular Closure Device (ACD), 8mm width

INTRINSIC THERAPEUTICS, INC.

Intervertebral disc prolapse repair implant
Primary Device IDM906BARA88MM0
NIH Device Record Key90841f30-f7da-4eb4-b3f4-ac71084bad20
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarricaid® ACD (Annular Closure Device)
Version Model Number8mm width
Catalog NumberBAR-A8-8MM
Company DUNS105722131
Company NameINTRINSIC THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone781.932.0222
Emailinfo@in-thera.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM906BARA88MM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QESReherniation Reduction Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-10
Device Publish Date2019-05-14

On-Brand Devices [Barricaid® ACD (Annular Closure Device)]

M906BARA810MM0Barricaid® Annular Closure Device (ACD), 10mm width/size.
M906BARA88MM0Barricaid® Annular Closure Device (ACD), 8mm width

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