FDA.report

Centurion

Primary DI
10653160127635
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
DT8615
Catalog number
DT8615
Device description
DR. THOM'S PRESSURE PACK
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, skin pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160127635PackageGS125In Commercial Distribution
00653160127638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316012763510653160127635
00653160127638006531601276386531601276380653160127638

GMDN Terms

TermDefinition
Pressure-management bandage, paddedA non-sterile padded material designed to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility in healthcare facilities. It is typically composed of a polyurethane foam layer bonded to a fabric layer (e.g., cotton, elastane, polyester) in the form of a tube intended to be worn on the limbs, or in the form of a flat sheet with fasteners intended to be worn around the pelvis to cover the sacral area. This is a single-patient, reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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