FDA UDI
In Commercial Distribution
🇺🇸 United States
UROLIFT
DI: 10814932020404
·
Model: IPN927552
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UROLIFT
- Primary DI
- 10814932020404
- Version / Model
- IPN927552
- Catalog Number
- UL400ATC
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-30
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- ceab96c8-ffc9-41f2-bba8-81ec6205ee36
Device Description
UroLift ATC System
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| PEW | Implantable transprostatic tissue retractor system | Gastroenterology, Urology | 876.5530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58882 | Prostatic retraction implant | A sterile implantable device intended to increase prostatic urethral patency, and thereby relieve lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH), by physically compressing the prostate gland by retraction. The implant is in the form of a two orthogonal tags (e.g., metal) held together by a suture (e.g., monofilament), and is introduced so that one tag is outside the prostatic capsule and the other is in the urethra, with the suture providing retraction. It is not intended to be explanted. The device is implanted using a dedicated, single-use, hand-held, pistol-like delivery device through the sheath of a rigid endoscope. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20814932020401 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 10814932020404 | GS1 |
Customer Contacts
- Phone
- +1(925)401-0700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200441 | 000 |