FDA UDI
In Commercial Distribution
🇺🇸 United States
HK Tumescent Infiltration Cannula, (8cm) 3"-16 gauge, Single Use, Box of 10
DI: 00816989020980
·
Model: SU-IC16x8
·
HK SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- HK Tumescent Infiltration Cannula, (8cm) 3"-16 gauge, Single Use, Box of 10
- Primary DI
- 00816989020980
- Version / Model
- SU-IC16x8
- Catalog Number
- SU-IC16x8
- Company Name
- HK SURGICAL INC.
- Labeler DUNS
- 106885259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-20
- Public Version
- 1
- Public Version Date
- 2020-11-30
- Public Version Status
- New
- Public Device Record Key
- 097a0ccc-cf7b-4c5e-b79f-40c0d743fa76
Device Description
HK Tumescent Infiltration Cannula, (8cm) 3"-16 gauge, Single Use, Box of 10
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
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 45414 | Liposuction system cannula, reusable | A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10816989020987 | GS1 | ||||
| Primary | 00816989020980 | GS1 |
Customer Contacts
- Phone
- 949-369-0101
- [email protected]