FDA UDI
In Commercial Distribution
🇺🇸 United States
Celluleaf
DI: 08721325283047
·
Model: CELL001
·
Aliform B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Celluleaf
- Primary DI
- 08721325283047
- Version / Model
- CELL001
- Company Name
- Aliform B.V.
- Labeler DUNS
- 494548366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 3
- Public Version Date
- 2025-09-10
- Public Version Status
- Update
- Public Device Record Key
- b927876f-e47d-44a6-b4d1-8cceeaa3621f
Device Description
Celluleaf - Surgical tool for subcutaneous blunt release of fibrous septae in soft tissues. The device is delivered sterile and intended for single use.
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
- No
- 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 |
|---|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62558 | General-purpose curette | A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08721325283047 | GS1 | ||||
| Package | 08721325283054 | GS1 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +31(0)686227637
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 60 Percent (%) Relative Humidity