FDA.reportPublic FDA data

CS Torso Support Medium Drape & MF

Primary DI
05060624123900
Brand
CS Torso Support Medium Drape & MF
Company
CARE SURGICAL LIMITED
Model
CSD-351-M-03
Catalog number
CSD-351-M-03
Published
2025-03-14
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
05060624123917PrimaryGS10
05060624123900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624123917050606241239175060624123917
05060624123900050606241239005060624123900

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
10
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
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
05060624126901Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126697CS Fixed Blade ClampCSM3043CSM30432025-12-17
05060624125157CS Extension Thigh Supports (Pair) - GreyCSM2744-GCSM2744-G2025-08-05
05060624125164CS Extension Hip Support - GreyCSM2950-GCSM2950-G2025-08-05
05060624125171CS Extension Thigh Support - Left (Grey)CSM2951-GCSM2951-G2025-08-05
05060624125188CS Extension Thigh Support - Right (Grey)CSM2952-GCSM2952-G2025-08-05
05060624127151CS Spine Frame Set - GreyCSM2715-GCSM2715-G2025-08-05
05060624122279CS Pad 3”CSM2568-3CSM2568-32025-08-04

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Primary DI, Brand, Company table
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08938504806793Pinnakle Moderate UnderpadPHU BAO GROUP COMPANY LIMITEDKME2025-05-30
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