FDA.reportPublic FDA data

Spencer

Primary DI
08057711230419
Brand
Spencer
Company
SPENCER ITALIA SRL
Model
SH00240A TANGO FIX - ADULT/PAEDIATRIC HEAD
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
IQKOrthosis, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057711230419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057711230419080577112304198057711230419

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, reusableA rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
442102067
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057711230402SpencerSH00201A SPENCER CONTOUR YELLOW/BLACK - AN.UN.HEAD2023-10-26
08057711231171SpencerSH00151A FXA PRO - ANATOMIC UNIVERSAL ANKLE IMMOBI2023-10-26
08057711231188SpencerSH00110C SUPER BLUE - FERMACAPO UNIV. COMPATTO BLU2023-10-26
08057711231195SpencerSH00111C SUPER BLUE YELLOW - COMPACT UNIV. HEAD IM2023-10-26
08057711231249SpencerSH00260A PEDI FIX PAEDIATRIC HEADIMMOBILISER2023-10-26
08057711231256SpencerSH00262A PEDI GO PAED. HEAD IMM. CUSH. FOR BABY GO2023-10-26
08057711237180SpencerST02035L ROCK-STRAPS – IMMOBILIZATION BELTS ADULT 2025-08-07
08057711230204SpencerST04519C STX 519 ADJUST. LIFTING BRID. - LIFTING B2023-10-26
08057711230228SpencerST04518A STX 518 2PIECES-UNI.FLOAT.SYS.FOR BASK. S2023-10-26
08057711230754SpencerSR00111B SED - SPENCER EXTRICATION DEVICE CON SACC2023-10-26
08057711231379SpencerQM40101A HIRVIN SIX HANDLES YELLOW2023-10-26
08057711231416SpencerQM40301A HIRVIN TEN HANDLES YELLOW2023-10-26
08057711231447SpencerQM40600B WOW - TRANSFER SHEET 10 HANDLES WITH FOOT2023-10-26
08057711230006SpencerST04000A SPENCER SHELL BASKET STRETCHER ORANGE2023-10-25
08057711230037SpencerST04012A SPENCER SHELL BASKET STRETCHER YELLOW2023-10-25
08057711230068SpencerST04020A TWIN SHELL ARANCIO C/3 CINT.+POGGIAP.+MAT2023-10-25
08057711230174SpencerST04070B DAKAR ORANGE WITH WHEELS MATTRESS/FOOTRES2023-10-25
08057711230969SpencerST04090A TOTAL - BARELLA DA RECUPERO GIALLA2023-10-25
08057711234226SpencerST05001B SXR RED KEY - BARELLA CUCCH. 3 LAME C/3 C2023-10-25
08057711230211SpencerST04525 STX 537 1PIECE-UNI. FLOAT. SYST. FOR BASK.2023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315226TrendOrthofix US LLCIQK2026-04-25
00850071315233TrendOrthofix US LLCIQK2026-04-14
00749756879699DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879705DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879712DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879729DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879736DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879750DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879767DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879774DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879804DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879811DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879828DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879835DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879989DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879996DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880008DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880084DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880091DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880107DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887601DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887618DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887625DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887632DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887649DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887656DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887687DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887694DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887700DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887717DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02