FDA UDI
In Commercial Distribution
🇺🇸 United States
Agili-C
DI: 07290019087175
·
Model: CHP0753
·
CARTIHEAL (2009) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Agili-C
- Primary DI
- 07290019087175
- Version / Model
- CHP0753
- Company Name
- CARTIHEAL (2009) LTD
- Labeler DUNS
- 533214388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 1
- Public Version Date
- 2023-06-08
- Public Version Status
- New
- Public Device Record Key
- 1c136833-f581-41fb-8780-57b846597d21
Device Description
3X Agili-C D7.5 Implant Pack
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 Safe
- 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 |
|---|---|---|---|---|
| QRU | Implant, Resorbable, For Articular Osteochondral Repair | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58054 | Osteochondral matrix implant | A sterile bioabsorbable device designed to be implanted to fill osteochondral defects. It is a porous and multilayered device, one layer of synthetic bone substitute material (e.g. ceramics such as tricalcium phosphate or hydroxyapatite) combined with a biological material (e.g., bovine collagen) intended to provide an osteoconductive bone tissue scaffold, and a second layer of predominantly biological material (e.g., bovine collagen) intended to provide a matrix structure that promotes the ingrowth of autologous cells for cartilage regeneration. Instruments to prepare the defect site and insert the implant may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019087175 | GS1 |
Customer Contacts
- Phone
- +97298810400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210034 | 000 |