FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756629183
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00749756629188DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629169DeRoyalDEROYAL INDUSTRIES, INC.EYH2021-07-12
50749756629176DeRoyalDEROYAL 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