FDA UDI
In Commercial Distribution
🇺🇸 United States
Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic.
DI: 07290015487092
·
Model: FAP7400000
·
ICECURE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cryoprobe D3.4 mm/10G, 185 mm, Pencil, Elliptic.
- Primary DI
- 07290015487092
- Version / Model
- FAP7400000
- Catalog Number
- FAP7400000
- Company Name
- ICECURE MEDICAL LTD
- Labeler DUNS
- 514758619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-24
- Public Version
- 5
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- 1ef81eec-2284-4eb9-a670-0e1fac75dfbc
Device Description
Cryoprobe-Use only with IceCure Cryogenic Device
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 878.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60508 | Hand-held cryosurgical system handpiece tip | A sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015487092 | GS1 |
Customer Contacts
- Phone
- 18889025716
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183213 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 185 | Millimeter | |
| Needle Gauge | 10 | Gauge |