FDA UDI
In Commercial Distribution
🇺🇸 United States
1.7 mm Long Shaft RenalCryo™ Cryoprobe
DI: 00810563020809
·
Model: DP35-0942-204
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 1.7 mm Long Shaft RenalCryo™ Cryoprobe
- Primary DI
- 00810563020809
- Version / Model
- DP35-0942-204
- Catalog Number
- RS-17L
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-18
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- 130846f6-e3be-4b68-801a-6dc9f85cd88a
Device Description
Right angle 1.7mm cryoprobe, oblong ice, long shaft, for use with Cryocare systems
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 45150 | Ophthalmic surgical procedure kit, non-medicated, single-use | A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810563020809 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153489 | 000 |