FDA.reportPublic FDA data

COVER, ILIAC PAD

Primary DI
00842430114533
Brand
COVER, ILIAC PAD
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5896-17
Catalog number
5896-8
Published
2020-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430104367PrimaryGS10
00842430114533Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430104367008424301043678424301043670842430104367
00842430114533008424301145338424301145330842430114533

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
12
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29
00842430109232PRONECONNECT MIRROR WITH POST HOLESPC580MPC580M2025-08-29
00842430109249PRONECONNECT TRIOS MIRROR PLATFORMPC700MPC700M2025-08-29
00842430109256PRONECONNECT CUSHION INSERT, SINGLE, SPC507EAPC507CS2025-08-29
00842430109263PRONECONNECT CUSHION INSERT, SINGLE, MPC505EAPC505CS2025-08-29
00842430109270PRONECONNECT CUSHION INSERT, SINGLE, LPC503EAPC503CS2025-08-29
00842430109287PRONECONNECT ADJUSTABLE HELMET & MIRRORPC510HMPC510HM2025-08-29
00842430109140ADANTE KNEE PROCEDURE KIT, LEFT6895K-L6895K-L2025-07-28
00842430109157ADANTE KNEE PROCEDURE KIT, RIGHT6895K-R6895K-R2025-07-28
00842430109164ADANTE DAA HIP PROCEDURE KIT, LEFT6895AH-L6895AH-L2025-07-28
00842430109171ADANTE DAA HIP PROCEDURE KIT, RIGHT6895AH-R6895AH-R2025-07-28
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPER3423-053423-052025-07-28
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
10842430111539PKIT, INDIV W/SHEARGARD, SST-3000 (1)5819-158192022-01-05

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Primary DI, Brand, Company table
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00850056748230FORWARD APLS Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-11-25
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50192253014424CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
00850061859785GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859792GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859808GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859815GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859822GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859839GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859846GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859853GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
16975675788564RESCUE ESSENTIALSEMSRUN GROUPKME2025-07-18
06931918194168AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
06931918129818HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
00616784134420DynaCare Disposable Underpads, Compressed Packaging, Absorbent Fluff Fill Dynarex CorporationKME2025-06-10
08938504806793Pinnakle Moderate UnderpadPHU BAO GROUP COMPANY LIMITEDKME2025-05-30
20889483602918AirLife™AirLife Finland OyKME2025-04-17
20889483602925AirLife™AirLife Finland OyKME2025-04-17
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20889483602949AirLife™AirLife Finland OyKME2025-04-17