FDA UDI
In Commercial Distribution
🇺🇸 United States
MultiCut Blade 350
DI: 04058784002037
·
Model: 839-3200-000
·
Asclepion Laser Technologies GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MultiCut Blade 350
- Primary DI
- 04058784002037
- Version / Model
- 839-3200-000
- Company Name
- Asclepion Laser Technologies GmbH
- Labeler DUNS
- 332247852
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- da2cd7cb-ad04-45f1-b999-ba42fc3b15a1
Device Description
Accessory (Blade) for Morcellator system "MultiCut Solo" Blade with 350 mm length, re-usable
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46729 | Tissue morcellation system | An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04058784002037 | GS1 |
Customer Contacts
- Phone
- +4936417700401
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240831 | 000 |