FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AVAflex
DI: 10885403164996
·
Model: AFH0011
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVAflex
- Primary DI
- 10885403164996
- Version / Model
- AFH0011
- Catalog Number
- AFH0011
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-12
- Public Version
- 3
- Public Version Date
- 2023-10-03
- Public Version Status
- Update
- Public Device Record Key
- 4656a4a5-aa2b-47f3-af2d-faa21a194b0d
- Distribution End Date
- 2018-04-12
Device Description
AVAFLEX™ VERTEBRAL AUGMENTATION NEEDLE 11G
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47129 | Balloon kyphoplasty kit | A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403164994 | GS1 | Case | 5 | Not in Commercial Distribution | 2018-04-12 |
| Primary | 10885403164996 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 11 | Gauge |