LPK10021 Lateral Positioning Kit

Primary DI
20787551040146
Brand
LPK10021 Lateral Positioning Kit
Company
XODUS MEDICAL, INC.
Model
LPK10021
Catalog number
LPK10021
Device description
LPK10021 Lateral Positioning Kit
Published
2023-06-26
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
CCXSUPPORT, PATIENT POSITION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551040146PackageGS11In Commercial Distribution
00787551040142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755104014620787551040146
00787551040142007875510401427875510401420787551040142

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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2078755104112940688 XL Advanced Trendelenburg Positioning Kit - Biodegradable40688406882025-04-16
20787551041136SPK11632 Jackson KitSPK11632SPK116322025-04-16
20787551041143CL25296 Custom Med Label PackCL25296CL252962025-04-16
20787551041150SPK11639 Wilson Table KitSPK11639SPK116392025-04-16
20787551041167SPK11638 Jackson Table KitSPK11638SPK116382025-04-16
20787551041174SPK11640 Surgical BackPack KitSPK11640SPK116402025-04-16

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