FDA.reportPublic FDA data

Spencer

Primary DI
08057711230754
Brand
Spencer
Company
SPENCER ITALIA SRL
Model
SR00111B SED - SPENCER EXTRICATION DEVICE CON SACC
Published
2023-10-26
Public version status
Update
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
08057711230754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057711230754080577112307548057711230754

GMDN Terms#

Term, Definition table
TermDefinition
Portable stretcherA hand-carried device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried. It is typically used to transport a patient from areas inaccessible to conventional ambulance stretchers (e.g., mountain or marine sites, difficult indoor situations such as narrow corridors or extremely steep stairways). The patient may be strapped to the device for security.

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
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
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