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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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