FDA.report

Techno-Aide

Primary DI
G242YVFPMR90
Brand
Techno-Aide
Company
Techno-Aide, Inc.
Model
YVFP-MR
Catalog number
YVFP-MR
Device description
MR Conditional Vinyl Covered Rectangle Bolster Sponge [24" x 18" x 4"]
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G242YVFPMR90PackageHIBCC1In Commercial Distribution
G242YVFPMR9PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify001

Sterilization Methods

Method

Contacts

PhoneEmail
+1(615)350-7030Customerservice@Techno-Aide.com

Regulatory Flags

DUNS number
843929279
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

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G242TB5R90Techno-AideTB-5RTB-5R2025-12-22
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G242YCADMR90Techno-AideYCAD-MRYCAD-MR2025-09-09
G242YCAKMR90Techno-AideYCAK-MRYCAK-MR2025-09-09
G242YCASMR90Techno-AideYCAS-MRYCAS-MR2025-09-09
G242YCBHMR90Techno-AideYCBH-MRYCBH-MR2025-09-09
G242YCBOMR90Techno-AideYCBO-MRYCBO-MR2025-09-09
G242YCDAMR90Techno-AideYCDA-MRYCDA-MR2025-09-09

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