FDA.report

NA

Primary DI
00810050243445
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9118
Device description
KIT, ACCESSORY LIGHTNING HIGH CAPACITY. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9077 - PAD, ROLLED EDGE FOOT EXTENSION (00810050241458), 9079 - SLIDE RAIL, DETACHABLE, LONG (10810050242858), 9111 - COVER, PROTECTIVE, AQUILLION ONE PAD (10810050242667), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30" (00810050242158), 9116 - PAD, TABLE, SHORT HEAVY (00810050241588)
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KXJTable, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050243445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050243445008100502434458100502434450810050243445

GMDN Terms

TermDefinition
Multifunction body cushionA soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081253414
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00810050245562NA335572025-09-24
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
10810050245446NA60002023-10-13
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00810050245470NA169-202023-05-01
00810050245487NA2-UF2023-05-01
00810050240840NA1592020-06-11
00810050243148NA128-UF2020-08-12
00810050245289NA1632022-05-27
00810050245302NA142-202022-05-27
00810050245456NA303-UF2022-11-18
00810050245432NA209-202022-11-10
00810050245401NA333502022-10-31
00810050245425NA108-82022-10-25

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00810050245524NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00810050245531NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00858340006448Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
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00887761973343Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761973350Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967625X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
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