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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
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

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