FDA UDI
In Commercial Distribution
🇺🇸 United States
WAL Infiltration Cannula
DI: 04260170880840
·
Model: Single-use, Ø=2.5, L=300, 0H, Infiltration
·
Human Med AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WAL Infiltration Cannula
- Primary DI
- 04260170880840
- Version / Model
- Single-use, Ø=2.5, L=300, 0H, Infiltration
- Catalog Number
- 1500127-5
- Company Name
- Human Med AG
- Labeler DUNS
- 332719157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-30
- Public Version
- 1
- Public Version Date
- 2025-08-07
- Public Version Status
- New
- Public Device Record Key
- 077e99d6-4635-4a34-86cd-57047eb2ba50
Device Description
WAL Infiltration Cannula, Ø=2,5mm, L=30cm, 0 Holes, Single-use, Infiltration
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36107 | Liposuction system cannula, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260170880840 | GS1 | ||||
| Package | 04260170880833 | GS1 | cardboard box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +49385395700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082025 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 8 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 40 Degrees Celsius