FDA.reportPublic FDA data

Sharn Inc

Primary DI
00817518021638
Brand
Sharn Inc
Company
Sharn Anesthesia
Model
PPD-LC250
Catalog number
PPD-LC250
Device description
LIGHT CLOUD PRONE POSITIONER 1/PK
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00817518021638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817518021638008175180216388175180216380817518021638

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-3671mailbox@sharn.com

Regulatory Flags#

DUNS number
107996118
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518020129Sharn IncBAT1-100BAT1-1002018-09-26
00817518022109Sharn IncS2020S20202018-11-16
00817518022123Sharn IncS2020-ES2020-E2018-11-16
00817518022147Sharn IncS2020-MS2020-M2018-11-16
00817518022161Sharn IncS2020-PS2020-P2018-11-16
00817518022550Sharn Anesthesia105604-EU2022-10-27
00817518022567Sharn Anesthesia105605-EU2022-10-27
00817518022574Sharn Anesthesia105606-EU2022-10-27
00817518022581Sharn Anesthesia105607-EU2022-10-27
00817518022598Sharn Anesthesia105608-EU2022-10-27
00817518022468SharnSelect45-18520SS2022-06-20
00817518022475SharnSelect45-18530SS2022-06-20
00817518022482SharnSelect45-18540SS2022-06-20
00817518022499SharnSelect45-18550SS2022-06-20
00817518022505SharnSelect45-18560SS2022-06-20
00817518022512SharnSelect45-18515SS2022-06-20
00817518022529SharnSelect45-18525SS2022-06-20
00817518022536SharnSelect45-185150SS2022-06-20
00817518022543SharnSelect45-185200SS2022-06-20
00817518021546Sharn IncPI-803S-6PI-803S-62018-10-10

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Primary DI, Brand, Company table
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07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19