FDA UDI
In Commercial Distribution
🇺🇸 United States
TAUT
DI: 14026704645227
·
Model: IPN914249
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- TAUT
- Primary DI
- 14026704645227
- Version / Model
- IPN914249
- Catalog Number
- 412944
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-16
- Public Version
- 2
- Public Version Date
- 2020-10-29
- Public Version Status
- Update
- Public Device Record Key
- a28ce166-8bff-4835-b57b-b779717d0e6a
Device Description
WECKVISTA ACCESS BALLOON PORT 12 MILLIMETER X 70 MILLIMETER
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35692 | Rigid endoscope obturator | An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704645224 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 14026704645227 | GS1 | ||||
| Package | 34026704645221 | GS1 | Box | 4 | In Commercial Distribution | |
| Previous | 04026704559763 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121796 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 70 | Millimeter | |
| Width | 12 | Millimeter |