FDA.report

XcelGel

Primary DI
00810048242009
Brand
XcelGel
Company
POLYMER CONCEPTS, INC.
Model
PC2225
Device description
PC2225 Gel Table Pad 25" x 22" x 1/2"
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LWGSurgical Table Cushion

Product Code Classifications

CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810048242009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048242009008100482420098100482420090810048242009

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
4409539605cust.serv@polymerconcept.com

Regulatory Flags

DUNS number
010560097
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850055249431Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249448Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249455Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249462Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249479Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249486Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249493Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249509Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249516Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249011Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249028Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249035Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249042Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249059Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249103Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249233Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249240Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249257Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249264Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249271Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249288Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249295Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249301Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249349Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249356Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249363Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249370Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249387Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249394Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249400Prime Medical LLCPrime Medical LLCLWG2026-03-05