Positioning Wedge 30-231-00

GUDID 10810044961086

Positioning Wedge 24" X 24" X 10.5"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use
Primary Device ID10810044961086
NIH Device Record Key07c068ea-fcba-4ebb-8ff3-72289ec8eb94
Commercial Distribution StatusIn Commercial Distribution
Brand NamePositioning Wedge
Version Model Number30-231-00
Catalog Number30-231-00
Company DUNS964459106
Company NameGENEVA HEALTHCARE, 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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044961089 [Primary]
GS110810044961086 [Package]
Contains: 00810044961089
Package: Case [2 Units]
In Commercial Distribution

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

Devices Manufactured by GENEVA HEALTHCARE, LLC

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10810044961628 - Disposable Stool Medical Mat2021-05-13 Disposable Stool Medical Mat, Columbia Blue - 13" x 17"
00810044961317 - Elbow & Heel Protector 2020-08-06 Pediatric Ulnar Nerve 7" x 4"
00810044961379 - Packaging Products2020-08-06 Pick & Shape Perforated Foam - Medium Square - 4" (1" x 1" Pick Square Size)
00810044961423 - Covered Cushions and Wedges2020-08-06 Convolute Top 10" Bed Wedge 10" x 24" x 24"
00810044961416 - Covered Cushions and Wedges2020-08-06 14" Molded Ring Cushion 2.25"x13"x15"
00810044961454 - Covered Cushions and Wedges2020-08-06 16" Molded Ring Cushion 2.75"x13.25"x16.5"

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