FDA.report

Pro-Tek-To Pad

Primary DI
00843696129286
Brand
Pro-Tek-To Pad
Company
FLOW X RAY CORPORATION
Model
75057-25
Device description
Pro-Tek-To Pad, Black
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KPYShield, Protective, Personnel

Product Code Classifications

CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843696129286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696129286008436961292868436961292860843696129286

GMDN Terms

TermDefinition
Patient radiation shielding pad/drape, reusableA protective device intended to be placed on/draped over part of a patient body (typically torso or chest) during a diagnostic or therapeutic radiological procedure, to shield specific patient anatomies from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
010016319
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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