FDA.reportPublic FDA data

XcelGel

Primary DI
00810048240821
Brand
XcelGel
Company
POLYMER CONCEPTS, INC.
Model
PC1051
Device description
"PC1051 Bariatric Lap Belt Pad Large 48"" x 7"" x 1/4"""
Published
2020-06-24
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
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
00810048240821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048240821008100482408218100482408210810048240821

GMDN Terms#

Term, Definition table
TermDefinition
Operating table 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4409539605cust.serv@polymerconcept.com

Regulatory Flags#

DUNS number
010560097
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810048240098XcelGelPC00332023-02-08
00810048240463XcelGelPC10232023-02-08
00810048240609XcelGelPC10352023-02-08
00810048241316XcelGelPC11002023-02-08
00810048241972XcelGelPC2207GP2023-02-08
00810048240630XcelGelPC10372023-02-07
00810048240876XcelGelPC10562023-02-07
00810048240883XcelGelPC10572023-02-07
00810048240890XcelGelPC10582023-02-07
00810048240906XcelGelPC10592023-02-07
00810048240913XcelGelPC10602023-02-07
00810048240920XcelGelPC10612023-02-07
00810048240937XcelGelPC10622023-02-07
00810048240944XcelGelPC10632023-02-07
00810048240951XcelGelPC10642023-02-07
00810048240968XcelGelPC10662023-02-07
00810048240975XcelGelPC10672023-02-07
00810048240982XcelGelPC10682023-02-07
00810048240999XcelGelPC10692023-02-07
00810048241002XcelGelPC10702023-02-07

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Primary DI, Brand, Company table
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10810087352223CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352230CoulmedCoulmed Products Group LLCLWG2023-01-06