FDA UDI
In Commercial Distribution
🇺🇸 United States
Barricaid® Narrow Anchor ACD Alignment Trial (8mm)
DI: M906AT8NARROW0
·
Model: 400943
·
INTRINSIC THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barricaid® Narrow Anchor ACD Alignment Trial (8mm)
- Primary DI
- M906AT8NARROW0
- Version / Model
- 400943
- Catalog Number
- AT-8-NARROW
- Company Name
- INTRINSIC THERAPEUTICS, INC.
- Labeler DUNS
- 105722131
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-15
- Public Version
- 1
- Public Version Date
- 2026-01-23
- Public Version Status
- New
- Public Device Record Key
- 87b53d5c-9ce4-4a0c-9ebe-a9a0ec9c50a2
Device Description
Narrow Alignment and sizing trial (8mm mesh size) used to support implantation of the Barricaid® Narrow Anchor ACD.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QES | Reherniation Reduction Device | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M906AT8NARROW0 | HIBCC |
Customer Contacts
- Phone
- 781.932.0222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160050 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 60 Degrees Celsius