FDA.reportPublic FDA data

NA

Primary DI
00810050245531
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9126
Device description
"Aquilion ONE INSIGHT Kit. 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), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30"" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30"" (00810050242158), 9121 – TABLE PAD COVER (00861001002659), 9125 – THE SHIELD, AQUILION ONE (00810050245524)"
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
FMQRestraint, Protective
IWYHolder, Head, Radiographic
KXJTable, Radiologic
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
FMQRestraint, ProtectiveGeneral Hospital1
IWYHolder, Head, RadiographicRadiology1
KXJTable, RadiologicRadiology2
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050245531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050245531008100502455318100502455310810050245531

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050241618NAVMR33PUBB2020-09-24
00810050243483NA90192020-09-24
00810050241120NAVMR38X012020-09-24
00810050242462NA9012-A2020-09-24
00810050242479N/A9012-B2020-09-24
00810050242486NA9012-C2020-09-24
00810050242493N/A9012-D2020-09-24
00810050242509NA9013-A2020-09-24
00810050242516N/A9013-B2020-09-24
00810050242523NA9013-C2020-09-24
00810050242530N/A9013-D2020-09-24
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
00810050245548NA60012024-12-31
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
00810050245449NA60002023-10-13

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00696588008448ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008455ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00198953183380NAGE Medical Systems, L.L.C.KXJ2026-11-03
00198953183434NAGE Medical Systems, L.L.C.KXJ2026-11-03
05060624129049Face Cushy Set (Helmet + Mirror)CARE SURGICAL LIMITEDCCX2026-11-03
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
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09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
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00850047863836CerviLockMedicalock CorporationCCX2026-09-24
04260114141488ThermAffyx™Stihler Electronic GmbHLWG2026-09-21
04260114141532ThermAffyx™Stihler Electronic GmbHLWG2026-09-21
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
10888277198739MEDLINEMEDLINE INDUSTRIES, INC.FMQ2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
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00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00810101280696sparrow swaddle™ - term infant sizeLITTLE SPARROWS TECHNOLOGIES LLCFMQ2026-07-27
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