FDA UDI
In Commercial Distribution
🇺🇸 United States
Flow-Screw™
DI: B26710280550
·
Model: 102-80-55
·
Flow-FX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flow-Screw™
- Primary DI
- B26710280550
- Version / Model
- 102-80-55
- Catalog Number
- 102-80-55
- Company Name
- Flow-FX
- Labeler DUNS
- 079293587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-18
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- b85450b3-3acb-4b6c-bb9e-9fff199aa5f9
Device Description
FS IO Adapter Long 5.5MM
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47737 | Orthopaedic cement injection cannula | A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B26710280550 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142776 | 000 |