FDA.report

XcelGel

Primary DI
00810048240753
Brand
XcelGel
Company
POLYMER CONCEPTS, INC.
Model
PC1045R
Device description
PC1045R Chest Positoner R 23/28" x 8" x 3"
Published
2020-06-22
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
00810048240753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048240753008100482407538100482407530810048240753

GMDN Terms

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

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

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