N/A

GUDID 00810050243384

POSITIONING KIT. Includes: 110 - WEDGE, 3” x 3” x 7.25” (10810050242957), 111 - WEDGE, 6.75” x 6.75” x 7.25” (00810050242332), 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 113 - WEDGE, 2.25” x 9.5” x 7.25” (10810050242926), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 151 - BLOCK, DECUBITUS, 4” x 18” x 24” (00810050240277), 153 - CYLINDER, 4.25” DIAMETER x 12” (00810050240406), 154 - MATTRESS, THIN, .25” x 18” x 24” (00810050240512), 171 - PAD, TABLE, 1” x 24” x 72” (00810050240420)

DOMICO MED-DEVICE, LLC

Multifunction body cushion
Primary Device ID00810050243384
NIH Device Record Key53a751ac-0887-4c5a-a617-05b36290bbf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number33254
Company DUNS081253414
Company NameDOMICO MED-DEVICE, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050243384 [Primary]

FDA Product Code

KXJTable, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

On-Brand Devices [N/A]

00810050242905Strap, Wide Security, 14.17 x 21.12
00810050243001WEDGE, TAPER, 1.50 X 3.50 X 3.00
00810050242998WEDGE, 3.75 X 9.00 X 8.00
00810050242981WEDGE, 3.50 X 7.00 X 8.00
00810050242967WEDGE, 3.00 X 4.00 X 7.00
00810050242936WEDGE, 2.50 X 7.00 X 10.00
00810050242912WEDGE 3.00 X 4.00 X 7.00
00810050242875STRAP, AUTO-TRACTION
00810050242868SLIDE RAIL, DETACHABLE, SHORT
00810050242844SLIDE RAIL, DETACHABLE, AQULION ONE
00810050242769REST, HEAD, 7.00 X 7.00 X 2.00
00810050242752RAIL, DETACHABLE 9.4mm x 28.5mm x 28" LONG
00810050242721INFINIX ARM SUPPORT
00810050242714HEAD-ENDS
00810050242691COVER, PROTECTIVE, SHORT SHIELD PAD
00810050242677COVER, PROTECTIVE, FOOT EXTENSION PAD
00810050242653COVER, PROTECTIVE, 31.00 X 93.75
00810050242639COVER, PROTECTIVE, 31.00 X 81.55
00810050243469KIT, STANDARD ACCESSORY, LONG TABLE. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP
00810050243438KIT, ACCESSORY LIGHTNING. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD
00810050243414KIT, ACCESSORY AQUILION ONE. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHE
00810050243407INFINIX & LUMINARY HEAD HOLDER KIT. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (1081005024
00810050243384POSITIONING KIT. Includes: 110 - WEDGE, 3” x 3” x 7.25” (10810050242957), 111 - WEDGE, 6.7
00810050243308KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 -
00810050243285KIT, ROUTINE X-RAY. Includes: 112-UF - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050240581),
00810050243261KIT, ORTHOPEDIC. Includes: 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 121 - BLOCK, OBLIQUE
00810050243247KIT, DELUXE. Includes: 110 - WEDGE, 3” x 3” x 7.25” (10810050242957), 111 - WEDGE, 6.75”
00810050243223Infinix Forehead Pad & Strap. Includes: 21577 - PAD, FOREHEAD, .50 X 2.00 X 6.00 (00810050242585
00810050243216AQUILION ONE HEAD HOLDER KIT. Includes: 9091 - HOLDER, AQUILION ONE CARBON FIBER (00810050241212
00810050243209KIT, ADULT HEAD REST. Includes: 9008A - REST, ADULT MEDIUM HEAD (00810050242455), 9008B - REST,
00810050242592STRAP, FOREHEAD, 2.00 X 60.00
00810050242547PAD, FOREHEAD
00810050242530CHILD HUGGER® TABLE ADAPTER
00810050242516CHILD HUGGER® BASE
00810050242493PEDIATRIC HUGGER® TABLE ADAPTER
00810050242479PEDIATRIC HUGGER® BASE
00810050242417WEDGE, 9.00 X 9.00 X 30.00
00810050242394WEDGE, 7.00 X 7.00 X 7.00
00810050242370WEDGE, 7.00 X 7.00 X 24.00
00810050242349WEDGE, 7.00 X 7.00 X 21.25
00810050242332WEDGE, 6.75 X 6.75 X 7.25
00810050242318WEDGE, 6.63 X 6.63 X 12.00
00810050242301WEDGE, 2.50 X 8.00 X 7.00
00810050242288CANON TABLE EXTENDER, BARIATRIC WIDE
00810050242264THE SHIELD, AQUILION ONE
00810050242240THE SHIELD, AQUILION, SHORT
00810050242226TABLE, EXTENDER REGULAR, PHILIPS BARIATRIC 7340
00810050242219TABLE PAD FOR 880B TABLE
00810050242202SYSTEM, UROLOGY BAG SUPPORT
00810050242189STRAP, WIDE SECURITY FOR GE SYSTEMS

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