FDA.reportPublic FDA data

CS Jackson Standard Hip & Thigh Covers - 4 piece

Primary DI
05060624123733
Brand
CS Jackson Standard Hip & Thigh Covers - 4 piece
Company
CARE SURGICAL LIMITED
Model
CSM 2610-2
Catalog number
CSM 2610-2
Published
2024-10-21
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

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
05060624120428PrimaryGS10
05060624123733Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624120428050606241204285060624120428
05060624123733050606241237335060624123733

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, single-useA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221313015
Device count
6
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
05060624129087CS Plexus Wedges (Pair)CSM2908CSM29082026-05-04
05060624128332Face Guard Cushion C-Flex925.FGC-CFLEX925.FGC-CFLEX2026-05-01
05060624123696CS Align Pro Support - Replacement PadsCSM2780CSM27802026-03-23
05060624126970CS Align Pro SupportCSM2781CSM27812026-03-23
05060624127182CS Easy Prone (170 mm) - GreyCSM2918-GCSM2918-G2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CSM2922-GCSM2922-G2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CSM3086CSM30862026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCSM2699-GCSM2699-G2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CSM2920-GCSM2920-G2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CSM2921-GCSM2921-G2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CSM2923-GCSM2923-G2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCSM2919-GCSM2919-G2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CSM2924-GCSM2924-G2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CSM2925-GCSM2925-G2026-01-26
05060624126918Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126901Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126697CS Fixed Blade ClampCSM3043CSM30432025-12-17
05060624126963CS FlexiFinless™ Stirrup Pads (Pair)CSM3053CSM30532025-10-31
05060624127670CS Blade Clamp Plus – EUCSM2767CSM27672025-10-14
05060624125157CS Extension Thigh Supports (Pair) - GreyCSM2744-GCSM2744-G2025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918186184InvenioGRI Medical & Electronic Technology Co., Ltd.KME2026-04-29
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918194165AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918129372HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11