PediatrOS™ FlexTack™/ RigidTack™
PediatrOS FlexTack/ RigidTack Chisel non-sterile
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Merete Gmbh, Germany |
|---|---|
| FDA product code | JYD |
| Device type | Chisel, Mastoid |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-01 |
| Record revised | 2023-04-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP10015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.