FDA.reportPublic FDA data

Cardinal Health

Primary DI
30748426123569
Brand
Cardinal Health
Company
Microtek Medical Inc.
Model
Organ Bag
Catalog number
29-10039
Device description
ISOLATION BAG 18X18.5IN CARDINAL
Published
2024-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30748426123569PackageGS110In Commercial Distribution
50748426123563PackageGS11In Commercial Distribution
00748426123568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074842612356930748426123569
5074842612356350748426123563
00748426123568007484261235687484261235680748426123568

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags#

DUNS number
106908437
Device count
1
DM exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10748426134806VELYS™Equipment Drapes4516-11-0182025-01-24
10748426134813VELYS™Equipment Drapes4516-11-0192025-01-24
10748426134820VELYS™Equipment Drapes4516-11-0202025-01-24
10748426137104MedtronicEquipment Drapes97327222024-11-05
10748426137111MedtronicEquipment Drapes97330232024-11-05
10748426137203Boston ScientificProbe Cover (BSC 3320)6633202024-10-22
50748426123976Zimmer BiometEquipment Drapes20-8020-080-002024-10-15
08425921000502MICROTEK12018-08-29
18425921000530MICROTEK12018-08-29
18425921000578MICROTEK12018-08-29
18425921000592MICROTEK12018-08-29
18425921000615MICROTEK12018-08-29
18425921000639MICROTEK12018-08-29
50748426130110DePuy Synthes VELYS4515700194515-70-0192023-03-09
30748426074946Microtek™9604UK9604UK2022-09-21
30748426132196CovidienPC-6X96PC-6X962022-08-16
30748426118527Skytron Lite-LokB1-020-99-2B1-020-99-22022-08-08
30748426118572Skytron ArgosB5-010-02-12022-08-08
08425921000038MICROTEK12018-08-29
18425921000059MICROTEK12018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00749756253956DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
50749756253951DeRoyalDEROYAL INDUSTRIES, INC.KGY2021-06-30
00827002156562LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157361LapSacCOOK INCORPORATEDKGY2020-10-02
00827002157378LapSacCOOK INCORPORATEDKGY2020-10-02