FDA UDI
In Commercial Distribution
🇺🇸 United States
FillerCollector
DI: 04260170881083
·
Model: Single-use FillerCollector, 250ml, Collect Fat
·
Human Med AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FillerCollector
- Primary DI
- 04260170881083
- Version / Model
- Single-use FillerCollector, 250ml, Collect Fat
- Catalog Number
- 1660000-5
- 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
- 9c11f6f6-e172-47d7-afdb-44ae0b975565
Device Description
Single-use FillerCollector - complete system for collection, filtration and concentration of fat tissue, 250ml
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 |
|---|---|---|---|---|
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260170881076 | GS1 | cardboard box | 5 | In Commercial Distribution | |
| Primary | 04260170881083 | GS1 |
Customer Contacts
- Phone
- +49385395700
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 35 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 8 – 35 Degrees Celsius