AccessGUDID - DEVICE: Barricaid® ACD (Annular Closure Device) (M906BARA810MM0)

GUDID

Device Identifier (DI) Information

Brand Name: Barricaid® ACD (Annular Closure Device)
Version or Model: 10mm width
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BAR-A8-10MM
Company Name: INTRINSIC THERAPEUTICS, INC.

Primary DI Number: M906BARA810MM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 105722131 *Terms of Use

Device Description: Barricaid® Annular Closure Device (ACD), 10mm width/size.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64194	Intervertebral disc prolapse repair implant	An implantable device intended to treat a prolapsed lumbar intervertebral disc by repairing the defect in the annulus fibrosus for the prevention of recurrent herniation of the nucleus pulposus. It consists of a mesh plug used to replace the disrupted segment of the annulus, and an attached anchor used to stabilize the plug by fixation to the adjacent vertebral body. It is made of polymer and metallic materials and implanted during a posterior approach procedure. Disposable devices associated with deployment (e.g., pusher, sheath) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QES	Reherniation Reduction Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160050	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d3b5769-495b-476a-9920-dc98786aadc0
Public Version Date: February 10, 2020
Public Version Number: 3
DI Record Publish Date: May 14, 2019