FDA UDI
In Commercial Distribution
🇺🇸 United States
Blunt Tip Microcannula Slim Fabinject 22G50MM
DI: 00850064466188
·
Model: BTC22G050BX10
·
FABINJECT LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Blunt Tip Microcannula Slim Fabinject 22G50MM
- Primary DI
- 00850064466188
- Version / Model
- BTC22G050BX10
- Company Name
- FABINJECT LLC
- Labeler DUNS
- 032329574
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- 99f35690-113b-4ff8-af34-567f6d7c3056
Device Description
Blunt Tip Microcannula Slim Fabinject 22G 50 mm, single use sterile pack with pilot needle - box with 10 units
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
- Yes
- 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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46676 | Tissue injection cannula | A thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850064466188 | GS1 | ||||
| Unit of Use | 10850064466185 | GS1 |
Customer Contacts
- Phone
- (321)972-4528
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 55 Degrees Celsius