FDA UDI
In Commercial Distribution
🇺🇸 United States
Leisegang Cryotip for LM-900
DI: 00888937000108
·
Model: 50115
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leisegang Cryotip for LM-900
- Primary DI
- 00888937000108
- Version / Model
- 50115
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-11
- Public Version
- 6
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 1a1e4e81-3515-4d20-956e-12a487d49817
Device Description
LT-2514 Jumbo Exo/Endocervical Cryotip 25mm x 17mm
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
- Yes
- 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
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 11067 | General cryosurgical system, cryogen gas, mechanical | An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937000108 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854767 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Millimeter | |
| Outer Diameter | 25 | Millimeter |