FDA UDI
In Commercial Distribution
🇺🇸 United States
Osteoamp Flowable Access Cannula
DI: 00816986020525
·
Model: OFAC-C
·
BIOVENTUS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Osteoamp Flowable Access Cannula
- Primary DI
- 00816986020525
- Version / Model
- OFAC-C
- Catalog Number
- OFAC-C
- Company Name
- BIOVENTUS LLC
- Labeler DUNS
- 078450878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-21
- Public Version
- 1
- Public Version Date
- 2024-11-29
- Public Version Status
- New
- Public Device Record Key
- d1009662-473f-44bb-b380-9fc817bb425d
Device Description
The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites.
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
- No
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47997 | Bone grafting cannula | A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816986020525 | GS1 |
Customer Contacts
- Phone
- 800-637-4391
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233368 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 11 – 30 Degrees Celsius