FDA UDI
In Commercial Distribution
🇺🇸 United States
CORUS™ Allograft Delivery Instrument
DI: 00852776006454
·
Model: PD-10-400
·
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CORUS™ Allograft Delivery Instrument
- Primary DI
- 00852776006454
- Version / Model
- PD-10-400
- Company Name
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-24
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0c57669b-d50b-40af-a21f-c29fabb991d5
Device Description
A manual orthopedic surgical instrument used to deliver structural bone graft to a target area of the spine. The Allograft Delivery Instrument is manufactured using medical grade polycarbonate resin and stainless steel. The CORUS™ Allograft Delivery Instrument is intended and indicated for the delivery of structural bone graft to a target area of the spine.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43999 | Bone graft syringe, single-use | A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852776006454 | GS1 | ||||
| Package | 10852776006451 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 4153013128
- [email protected]