FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PROFORMA
DI: 20653405051418
·
Model: 050906
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- PROFORMA
- Primary DI
- 20653405051418
- Version / Model
- 050906
- Catalog Number
- 050906
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- b67177cd-b360-470e-a993-c0c41eea46f2
- Distribution End Date
- 2017-04-04
Device Description
PROFORMA HF 4.5 Cannula, Straight Taper Tip
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
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16429 | ERCP catheter, non-balloon, non-electrical, single-use | A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653405051411 | GS1 | BOX | 5 | Not in Commercial Distribution | 2017-04-04 |
| Primary | 20653405051418 | GS1 | ||||
| Unit of Use | 00653405051414 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950700 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1.5 Millimeter Catheter Gauge | ||
| Device Size Text, specify | 1.7 Millimeter Catheter Gauge Diameter | ||
| Device Size Text, specify | 0.89 Millimeter Wire Outer Diameter | ||
| Length | 190 | Centimeter | |
| Catheter Gauge | 4.5 | French | |
| Device Size Text, specify | 0.035 Inch Wire Outer Diameter | ||
| Device Size Text, specify | 7-5 French Catheter Gauge Catheter Diameter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 49 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 120 Degrees Fahrenheit