Oakworks, Inc.

GUDID 00817463022544

Spine Positioning System II Large Torso - TT/EM

OAKWORKS, INC.

Head/neck procedure positioner
Primary Device ID00817463022544
NIH Device Record Key4530ee91-6178-467a-9782-8276d816e606
Commercial Distribution StatusIn Commercial Distribution
Brand NameOakworks, Inc.
Version Model NumberSpine Positioning System II
Company DUNS130256837
Company NameOAKWORKS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817463022544 [Primary]

FDA Product Code

KXHCradle, Patient, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-12

On-Brand Devices [Oakworks, Inc.]

00817463022544Spine Positioning System II Large Torso - TT/EM
00817463022537Spine Positioning System II Large Torso - TT
00817463022452Prone Pillow
00817463022445Interventional Supine Pillow System
00817463022438Patient Safety Strap
00817463022421Arm Hammock

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