FDA UDI
In Commercial Distribution
🇺🇸 United States
COLEMAN Multi-Hole Aspiration Cannula 12ga x 26cm
DI: 00081317023647
·
Model: COL-H1226
·
MENTOR TEXAS L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COLEMAN Multi-Hole Aspiration Cannula 12ga x 26cm
- Primary DI
- 00081317023647
- Version / Model
- COL-H1226
- Catalog Number
- COL-H1226
- Company Name
- MENTOR TEXAS L.P.
- Labeler DUNS
- 167450993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- 3764af64-19ae-475a-b532-d3aa39368970
Device Description
COLEMAN Multi-Hole Aspiration Cannula 12ga x 26cm
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MUU | System, suction, lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00081317023647 | GS1 |
Customer Contacts
- Phone
- +1(800)235-5731
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981172 | 000 |