FDA UDI
In Commercial Distribution
🇺🇸 United States
TruCath
DI: 00850045818357
·
Model: RR16
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TruCath
- Primary DI
- 00850045818357
- Version / Model
- RR16
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 1
- Public Version Date
- 2025-02-03
- Public Version Status
- New
- Public Device Record Key
- 5b25ed03-ee75-447a-887a-1af5c5cfc936
Device Description
TruCath® Red Rubber Intermittent Urethral Catheter, 16 Fr 16" Length
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| EYB | CATHETER, URETERAL, GASTRO-UROLOGY | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34926 | Ureteral catheter | A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850045818354 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00850045818357 | GS1 | ||||
| Package | 50850045818352 | GS1 | Case | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 110
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius