FDA.reportPublic FDA data

Coulmed

Primary DI
10810087351059
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
GP114
Catalog number
GP114
Device description
"Gel Pad: 37""L x 12""W x 1""T"
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10810087351059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081008735105910810087351059

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, reusableA 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 reusable device.

Regulatory Flags#

DUNS number
047115479
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810087352605CoulmedAC28-PAC28-P2023-01-06
10810087352612CoulmedAC3300-BPAC3300-BP2023-01-06
10810087352629CoulmedAC3400-BPAC3400-BP2023-01-06
10810087352636CoulmedAC3800-BPAC3800-BP2023-01-06
10810087352643CoulmedAC3800-BP-LAC3800-BP-L2023-01-06
10810087352650CoulmedAC3800-BP-RAC3800-BP-R2023-01-06
10810087352667CoulmedAC3900-BPAC3900-BP2023-01-06
10810087350007CoulmedDI-5403DI-54032023-01-06
10810087350014CoulmedDI-5404DI-54042023-01-06
10810087350021CoulmedDI-5406DI-54062023-01-06
10810087350038CoulmedDI-5408DI-54082023-01-06
10810087350045CoulmedDI-5414DI-54142023-01-06
10810087350052CoulmedDI-5415DI-54152023-01-06
10810087350069CoulmedDI-5416DI-54162023-01-06
10810087350076CoulmedDI-5419DI-54192023-01-06
10810087350083CoulmedDI-5420DI-54202023-01-06
10810087350090CoulmedDI-5424DI-54242023-01-06
10810087350106CoulmedDI-5503DI-55032023-01-06
10810087350113CoulmedDI-6101DI-61012023-01-06
10810087350120CoulmedDI-6102DI-61022023-01-06

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
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
10810087352247CoulmedCoulmed Products Group LLCLWG2023-01-06