FDA.reportPublic FDA data

ThermAffyx™

Primary DI
04260114141532
Brand
ThermAffyx™
Company
Stihler Electronic GmbH
Model
365
Catalog number
90365
Device description
ThermAffyx™ Heated Securement Pad Kit
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2
LWGSurgical Table CushionGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260278000ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH2026-07-08DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260114141501Direct MarkingGS10
04260114141525PackageGS14In Commercial Distribution
04260114141532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260114141501042601141415014260114141501
04260114141525042601141415254260114141525
04260114141532042601141415324260114141532

GMDN Terms#

Term, Definition table
TermDefinition
Operating table non-slip back padA non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
317742377
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
04260114141488ThermAffyx™364903642026-09-21
04260114140221ASTOPAD®COV070-NACOV070-NA2020-10-08
04260114140238ASTOPAD®COV105-NACOV105-NA2020-10-08
04260114140245ASTOPAD®COV150-NACOV150-NA2020-10-08
04260114140252ASTOPAD®COV155-NACOV155-NA2020-10-08
04260114140269ASTOPAD®COV180-NACOV180-NA2020-10-08
04260114140030ASTOPAD®DUO310-NADUO310-NA2020-10-07
04260114141433ASTOTUBE®M77455502M774555022024-08-16
04260114141440ASTOTUBE®M774600022024-08-16
04260114141389ASTOTUBE®M77455502M774555022024-08-16
04260114141396ASTOTUBE®M774600022024-08-16
04260114140610ASTOTUBE®IFT40410IFT404102016-09-07
04260114140627ASTOTUBE®IFT30350IFT303502016-09-07
04260114140634ASTOTUBE®IFT30460IFT304602016-09-07
04260114140641ASTOTUBE®IFT30410IFT304102016-08-11
04260114140214ASTODIADIA1002023-07-18
04260114140375ASTOTHERM® PLUSAP220EUAP220EU2016-08-31
04260114140382ASTOTHERM® PLUSAP220SEUAP220SEU2016-08-31
04260114140399ASTOTHERM® PLUSAP260EUAP260EU2016-08-31
04260114140405ASTOTHERM® PLUSAP260SEUAP260SEU2016-08-31

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Primary DI, Brand, Company table
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