FDA.reportPublic FDA data

Prime Medical LLC

Primary DI
00855085005712
Brand
Prime Medical LLC
Company
Prime Medical LLC
Model
PrimePad-SQ1
Catalog number
PrimePad-SQ1
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855085005712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855085005712008550850057128550850057120855085005712

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

Regulatory Flags#

DUNS number
078682939
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055249431Prime Medical LLCPrimePadPlus-K1-212026-03-06
00850055249448Prime Medical LLCPrimePadPlus-K3-212026-03-06
00850055249455Prime Medical LLCPrimePadPlus-K5-212026-03-06
00850055249462Prime Medical LLCPrimePadPlus-K6-212026-03-06
00850055249479Prime Medical LLCPrimePadPlus-K7-212026-03-06
00850055249486Prime Medical LLCPrimePadPlus-K8-212026-03-06
00850055249493Prime Medical LLCPrimePadPlus-W1-212026-03-06
00850055249509Prime Medical LLCPrimePadPlus-W2-212026-03-06
00850055249516Prime Medical LLCPrimePadPlus-k9-212026-03-06
00850055249011Prime Medical LLCPrimePadPlus-K122026-03-05
00850055249028Prime Medical LLCPrimePadPlus-K142026-03-05
00850055249035Prime Medical LLCPrimePadPlus-K152026-03-05
00850055249042Prime Medical LLCPrimePadPlus-1S-212026-03-05
00850055249059Prime Medical LLCPrimePadPlus-K2-212026-03-05
00850055249066Prime Medical LLCPHP1002026-03-05
00850055249103Prime Medical LLCPrimePadPlus-1-212026-03-05
00850055249134Prime Medical LLCPPOST62026-03-05
00850055249141Prime Medical LLCTP-100-HAN2026-03-05
00850055249165Prime Medical LLCDDS1002026-03-05
00850055249172Prime Medical LLCJTK1002026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810087350946CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350953CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350960CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087353343CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087354005CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350908CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350915CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350922CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350939CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350977CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350984CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350991CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351004CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351028CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351035CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351042CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351059CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351066CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351080CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351097CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351387CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352001CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352162CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352179CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352186CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352193CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352209CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352216CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352223CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352230CoulmedCoulmed Products Group LLCLWG2023-01-06