FDA UDI
In Commercial Distribution
🇺🇸 United States
C2 CryoBalloon
DI: 04961333255320
·
Model: FG-1056
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- C2 CryoBalloon
- Primary DI
- 04961333255320
- Version / Model
- FG-1056
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-12
- Public Version
- 2
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- 7205cda9-47ef-40f9-8812-89db6e4c5630
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 45712 | Gastrointestinal/biliary dilation balloon catheter, non-medicated | A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333255320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240457 | 000 |