FDA UDI
In Commercial Distribution
🇺🇸 United States
iTind Removal Kit
DI: 07290015518192
·
Model: MT-FA08
·
MEDI-TATE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iTind Removal Kit
- Primary DI
- 07290015518192
- Version / Model
- MT-FA08
- Company Name
- MEDI-TATE LTD
- Labeler DUNS
- 532003626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- d060eec4-b401-4abd-89b6-1aea18d56567
Device Description
iTind Removal Kit: 1 Snare + 1 Removal Tube
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 |
|---|---|---|---|---|
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | Gastroenterology, Urology | 876.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63402 | Bare-metal urethral stent, short-term | A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is made entirely of metal [e.g., nickel-titanium alloy (Nitinol)] and is typically self-expanded in situ; disposable devices intended to assist implantation or removal (e.g., attached thread) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015518192 | GS1 |
Customer Contacts
- Phone
- +972777006745
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN190020 | 000 |