FDA UDI
In Commercial Distribution
🇺🇸 United States
Strauss Surgical
DI: 00850033250657
·
Model: STS-URO-400-00
·
AMERICAN MEDICAL ENDOSCOPY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Strauss Surgical
- Primary DI
- 00850033250657
- Version / Model
- STS-URO-400-00
- Company Name
- AMERICAN MEDICAL ENDOSCOPY, INC.
- Labeler DUNS
- 024725124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-12
- Public Version
- 1
- Public Version Date
- 2022-08-22
- Public Version Status
- New
- Public Device Record Key
- 7d88f0be-2167-4c69-8594-f8ed2035ed8e
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37143 | Bladder evacuator, reusable | A hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033250657 | GS1 |