Hand Grip

Primary DI
B365601400
Brand
Hand Grip
Company
Aktina Corp.
Model
60-140
Published
2021-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103616000
K991546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103616000PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZERAktina Medical Physics Corp.2011-01-25IYE
K991546000AKTINA MEDICAL PHYSICS CORPORATION TILT BOARDAktina Medical Physics Corp.1999-07-30IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365601400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B365503022100Circular Small Field Cone Insert, Elekta, 21mm50-302-2102016-10-04
B365503022200Circular Small Field Cone Insert, Elekta, 22mm50-302-2202016-10-04
B365503022300Circular Small Field Cone Insert, Elekta, 23mm50-302-2302016-10-04
B365503022400Circular Small Field Cone Insert, Elekta, 24mm50-302-2402016-10-04
B365503022500Circular Small Field Cone Insert, Elekta, 25mm50-302-2502016-10-04
B365503022600Circular Small Field Cone Insert, Elekta, 26mm50-302-2602016-10-04
B365503022700Circular Small Field Cone Insert, Elekta, 27mm50-302-2702016-10-04
B365503022800Circular Small Field Cone Insert, Elekta, 28mm50-302-2802016-10-04
B365503022900Circular Small Field Cone Insert, Elekta, 29mm50-302-2902016-10-04
B365503023000Circular Small Field Cone Insert, Elekta, 30mm50-302-3002016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
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