FDA.reportPublic FDA data

Spencer

Primary DI
08057711230600
Brand
Spencer
Company
SPENCER ITALIA SRL
Model
JM30021 SPECTAR FOAM CERVICAL COLLAR BIVALVE SIZE
Published
2023-10-26
Public version status
New
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
08057711230600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057711230600080577112306008057711230600

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, single-useA prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use device.

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
08057711230419SpencerSH00240A TANGO FIX - ADULT/PAEDIATRIC 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

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