FDA.reportPublic FDA data

Spencer

Primary DI
08057711233403
Brand
Spencer
Company
SPENCER ITALIA SRL
Model
ST00480C FIXO KID - PEDIATRIC RESTRAINT SYSTEM
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057711233403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057711233403080577112334038057711233403

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable 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
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IQE2025-08-05
00636257203651MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203668MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203675MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203682MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203699MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203705MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203712MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203729MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203736MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203743MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203750MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203767MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204801MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204818MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204825MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204832MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204849MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204856MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204863MEDIMEDI MANUFACTURING, INC.IQE2025-06-24