FDA UDI
In Commercial Distribution
🇺🇸 United States
UniTip High Resolution Catheter
DI: 07640172970058
·
Model: K102459-E-1531-D
·
Unisensor AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UniTip High Resolution Catheter
- Primary DI
- 07640172970058
- Version / Model
- K102459-E-1531-D
- Company Name
- Unisensor AG
- Labeler DUNS
- 483298907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 011c7b93-fef7-421a-b6f3-a7dff3270012
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFX | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62242 | Gastrointestinal motility manometric catheter, electronic | A flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. Also known as a GI solid-state sensor catheter, it is intended for proximal connection to an appropriate gastrointestinal motility analysis system, and the acquired data may be used to generate a 3-D image. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640172970058 | GS1 |
Customer Contacts
- Phone
- +1(603)570-2675
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062222 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French |