FDA.reportPublic FDA data

Techno-Aide

Primary DI
G242YXAAMR90
Brand
Techno-Aide
Company
Techno-Aide, Inc.
Model
YXAA-MR
Catalog number
YXAA-MR
Device description
MR Conditional Closed Cell Finger Block Sponge [5" x 5" x 3"]
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G242YXAAMR90PackageHIBCC1In Commercial Distribution
G242YXAAMR9PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify001

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G242TB3L90Techno-AideTB-3LTB-3L2025-12-22
G242TB3R90Techno-AideTB-3RTB-3R2025-12-22
G242TB5L90Techno-AideTB-5LTB-5L2025-12-22
G242TB5R90Techno-AideTB-5RTB-5R2025-12-22
G242TC3L90Techno-AideTC-3LTC-3L2025-12-22
G242TC3N90Techno-AideTC-3NTC-3N2025-12-22
G242TC3R90Techno-AideTC-3RTC-3R2025-12-22
G242TC5L90Techno-AideTC-5LTC-5L2025-12-22
G242YCBJMR90Techno-AideYCBJ-MRYCBJ-MR2025-09-12
G242YVFUMR90Techno-AideYVFU-MRYVFU-MR2025-09-12
G242SB03RDBKMR90Techno-AideSB-03R-DBK-MRSB-03R-DBK-MR2025-09-09
G242SB07SDBKMR90Techno-AideSB-07S-DBK-MRSB-07S-DBK-MR2025-09-09
G242SB12RDBKMR90Techno-AideSB-12R-DBK-MRSB-12R-DBK-MR2025-09-09
G242SS03DBKMR90Techno-AideSS-03-DBK-MRSS-03-DBK-MR2025-09-09
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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Primary DI, Brand, Company table
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20665973020932DukalDukal LLCNAB2026-01-30
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00810194401787AiraAIRA, LLCNAB2026-01-16
00810194401824AiraAIRA, LLCNAB2026-01-16
00810194401831AiraAIRA, LLCNAB2026-01-16
00810194401848AiraAIRA, LLCNAB2026-01-16
00810194401855AiraAIRA, LLCNAB2026-01-16
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00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
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