ArmCradle4

GUDID B365608120

Aktina Corp.

Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable
Primary Device IDB365608120
NIH Device Record Keyc0850ce3-c211-448b-a495-65fca05a4e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameArmCradle4
Version Model Number60-812
Company DUNS787178920
Company NameAktina Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]
HIBCCB365608120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by Aktina Corp.

B365407411 - Thermoplastic Shoulder Mask2021-01-13
B365508070 - Arch Kit, PositionPro2021-01-13
B365508300 - ShoulderAssist, PositionPro2021-01-13
B365508320 - ArmAssist, PositionPro2021-01-13
B365608120 - ArmCradle42021-01-13
B365608120 - ArmCradle42021-01-13
B365407221 - PosiLok Standard Mask Kit2020-07-29
B365407231 - PosiLok Enhanced Mask Kit2020-07-29
B365407321 - Posterior Mask2020-07-29

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