FDA UDI
In Commercial Distribution
🇺🇸 United States
STERiGLIDE TM
DI: 04580708061740
·
Model: SGC-25050
·
TSK LABORATORY, JAPAN
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
750
Basic Information
- Brand Name
- STERiGLIDE TM
- Primary DI
- 04580708061740
- Version / Model
- SGC-25050
- Company Name
- TSK LABORATORY, JAPAN
- Labeler DUNS
- 690646096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 750
- Record Status
- Published
- Publish Date
- 2022-04-07
- Public Version
- 2
- Public Version Date
- 2022-07-28
- Public Version Status
- Update
- Public Device Record Key
- 46b73483-5b56-41aa-a66b-249024b36572
Device Description
CANNULA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 14580708061747 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 04580708061740 | GS1 | ||||
| Package | 24580708061744 | GS1 | 1 | In Commercial Distribution | ||
| Unit of Use | 04571225316260 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.5 | Millimeter |