Jay Syncra Back JAY

GUDID 00016958059878

Syncra is a comprehensive seating system engineered so that the cushion and the back work in tandem to minimize movement and help avoid body displacement. The combination of the Syncra's scalloped back shell and the cushions' lowered pelvic wall and deeper femoral troughs assist in keeping the body in optimal position during the recline motion.

SUNRISE MEDICAL (US) LLC

Gel-filled chair cushion
Primary Device ID00016958059878
NIH Device Record Key2dc5d4cc-21d4-456d-bed5-f17ba61cc5ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameJay Syncra Back
Version Model NumberSyncra Back
Catalog NumberJAY
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958059878 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-27
Device Publish Date2023-09-19

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