FDA.reportPublic FDA data

Prime Medical LLC

Primary DI
00855085005835
Brand
Prime Medical LLC
Company
Prime Medical LLC
Model
PrimePad-1-21
Catalog number
PrimePad-1-21
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
00855085005835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855085005835008550850058358550850058350855085005835

GMDN Terms#

Term, Definition table
TermDefinition
Operating table non-slip back padA non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. 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

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Primary DI, Brand, Company table
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10810087353343CoulmedCoulmed Products Group LLCLWG2023-01-12
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10810087350984CoulmedCoulmed Products Group LLCLWG2023-01-06
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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