FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Barricaid ACD Retraction Wedge
DI: M906WED1A0
·
Model: 400846
·
INTRINSIC THERAPEUTICS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Barricaid ACD Retraction Wedge
- Primary DI
- M906WED1A0
- Version / Model
- 400846
- Catalog Number
- WED-1-A
- Company Name
- INTRINSIC THERAPEUTICS, INC.
- Labeler DUNS
- 105722131
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-14
- Public Version
- 5
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 5c5aa3e8-e376-4695-a75a-2dd8b49c774b
- Distribution End Date
- 2020-03-31
Device Description
Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable wedge designed to help pull back the strike cap following full Barricaid deployment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13180 | Orthopaedic prosthesis implantation positioning instrument, reusable | A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M906WED1A0 | HIBCC |