FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756253956
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-5510
Catalog number
30-5510
Device description
Isolation Transport Bag
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGYBAG, INTESTINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGYBag, IntestineGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756253951PackageGS140In Commercial Distribution
00749756253956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975625395150749756253951
00749756253956007497562539567497562539560749756253956

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative procedure bagA sterile flexible container used to temporarily isolate a patient body part/organ during a surgical procedure, typically to segregate it from the surgical site. The device may be used to: 1) cover a dirty body part (e.g., hand/foot) to prevent cross-contamination with the surgical site; 2) cover a clean body part (e.g., hand/foot) while performing surgery on another site (e.g., leg/knee); 3) retain organs during abdominal surgery; or 4) keep organs (e.g., intestines) moist during surgery. It is typically made of a soft, strong, clear plastic film with a seamless bottom and draw strings at the opening to create a seal around the chosen body part/organ. This is a single-use device.

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
50885380153875CARDINAL HEALTHCardinal Health 200, LLCKGY2026-06-24
507073870711913M™ Steri-Drape™3M COMPANYKGY2026-04-17
10885632426605HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20885632426602HALYARDOWENS & MINOR DISTRIBUTION, INC.KGY2026-02-05
20748426262599Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00748426262595Medline-MicrotekMicrotek Medical LLCKGY2026-01-19
00888937027891LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027907LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027914LapSacCoopersurgical, Inc.KGY2025-09-03
00888937027884LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027895LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027901LapSacCoopersurgical, Inc.KGY2025-09-03
20888937027918LapSacCoopersurgical, Inc.KGY2025-09-03
00748426144037Medline-MicrotekMicrotek Medical LLCKGY2025-07-28
10748426144034Medline-MicrotekMicrotek Medical LLCKGY2025-07-28
10192253067873CONVERTORSCardinal Health 200, LLCKGY2025-06-30
50192253067871CONVERTORSCardinal Health 200, LLCKGY2025-06-30
16931918131153AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
06931918131156AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2025-06-20
00748426123568Cardinal HealthMicrotek Medical LLCKGY2024-09-26
30748426123569Cardinal HealthMicrotek Medical Inc.KGY2024-09-26
16931918199078AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
26931918199075AllesetGRI Medical & Electronic Technology Co., Ltd.KGY2023-07-20
G026085001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026086001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026087001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
G026088001P&P Medical Surgical LLCP&P Medical Surgical LLCKGY2022-02-11
50749756253951DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
00827002156562LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157361LapSacCOOK INCORPORATEDKGY2020-10-02