FDA.reportPublic FDA data

PAD, SUPINE IMAGING TOP

Primary DI
00842430100529
Brand
PAD, SUPINE IMAGING TOP
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
6988-442
Catalog number
6988-442
Published
2021-10-22
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430100529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430100529008424301005298424301005290842430100529

GMDN Terms#

Term, Definition table
TermDefinition
Operating table mattress, basicA foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
084527241
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
true
Expiration date on label
false
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
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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