FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756629188
·
Model: 71-CPSK
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756629188
- Version / Model
- 71-CPSK
- Catalog Number
- 71-CPSK
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-12
- Public Version
- 1
- Public Version Date
- 2021-07-20
- Public Version Status
- New
- Public Device Record Key
- 08f8fb48-a783-425b-bfd5-2ea21eb9d2cf
Device Description
Cysto Pouch, Skytron Table
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYH | TABLE, CYSTO, NON-ELECTRICAL | Gastroenterology, Urology | 876.4890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38520 | Urological operating table, hydraulic | A mobile table powered by manually-operated hydraulic mechanisms designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Commonly known as a transurethral resection (TUR) table, its surface consists of a flat section with a headrest; it includes adjustable leg holders/stirrups either directly attached to the table or to its side rails. It may also include traction handles and an integrated urine/irrigation fluid collection tray with a filter to catch urinary stones and/or stone fragments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756629183 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00749756629188 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]