FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756629188
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
71-CPSK
Catalog number
71-CPSK
Device description
Cysto Pouch, Skytron Table
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYHTABLE, CYSTO, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYHTable, Cysto, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756629183PackageGS110In Commercial Distribution
00749756629188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975662918350749756629183
00749756629188007497566291887497566291880749756629188

GMDN Terms#

Term, Definition table
TermDefinition
Urological operating table, hydraulicA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07467423230569SterimedDAS Medical International SRLEYH2025-12-11
07467423230576SterimedDAS Medical International SRLEYH2025-12-11
07467423230606SterimedDAS Medical International SRLEYH2025-12-11
07467423230613SterimedDAS Medical International SRLEYH2025-12-11
07467423230620SterimedDAS Medical International SRLEYH2025-12-11
17467423230566SterimedDAS Medical International SRLEYH2025-12-11
17467423230573SterimedDAS Medical International SRLEYH2025-12-11
17467423230603SterimedDAS Medical International SRLEYH2025-12-11
17467423230610SterimedDAS Medical International SRLEYH2025-12-11
17467423230627SterimedDAS Medical International SRLEYH2025-12-11
07467423230651SterimedDAS Medical International SRLEYH2025-12-08
17467423230658SterimedDAS Medical International SRLEYH2025-12-08
00749756629164DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
00749756629171DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629169DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629176DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629183DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
07466532979116SchaererDAS Medical International SRLEYH2021-05-03
17466532979113SchaererDAS Medical International SRLEYH2021-05-03
00860001790221SterimedSTERIMED LLCEYH2020-09-21
00860001790238SterimedSTERIMED LLCEYH2020-09-21
00860001790245SterimedSTERIMED LLCEYH2020-09-21
00860001790252SterimedSTERIMED LLCEYH2020-09-21
00860001790269SterimedSTERIMED LLCEYH2020-09-21
00860001790276SterimedSTERIMED LLCEYH2020-09-21
00860001790283SterimedSTERIMED LLCEYH2020-09-21
10860001790228SterimedSTERIMED LLCEYH2020-09-21
10860001790235SterimedSTERIMED LLCEYH2020-09-21
10860001790242SterimedSTERIMED LLCEYH2020-09-21
10860001790259SterimedSTERIMED LLCEYH2020-09-21