FDA UDI
In Commercial Distribution
🇺🇸 United States
STERiGLIDE TM
DI: 04580708061597
·
Model: SGC-27050
·
TSK LABORATORY, JAPAN
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- STERiGLIDE TM
- Primary DI
- 04580708061597
- Version / Model
- SGC-27050
- Company Name
- TSK LABORATORY, JAPAN
- Labeler DUNS
- 716217877
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-08-22
- Public Version
- 1
- Public Version Date
- 2022-08-30
- Public Version Status
- New
- Public Device Record Key
- 358ae6e5-64be-47b8-975a-25bca9dfa45b
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 | 14580708061594 | GS1 | 75 | In Commercial Distribution | ||
| Primary | 04580708061597 | GS1 | ||||
| Unit of Use | 04571225316321 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 50 | Millimeter | |
| Outer Diameter | 0.4 | Millimeter |