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
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18
00749756401753DeRoyal23-800P23-800P2026-09-18
00749756401760DeRoyal23-806P23-806P2026-09-18
00749756401777DeRoyal23-805P23-805P2026-09-18
00749756401784DeRoyal23-801P23-801P2026-09-18
00749756401920DeRoyal46-LT5S-05B46-LT5S-05B2026-09-18
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22

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