FDA.reportPublic FDA data

Spencer

Primary DI
08057711230945
Brand
Spencer
Company
SPENCER ITALIA SRL
Model
ST02015A PIN STRAPS - SISTEMA DI CINTURE CON GANCI
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
NZDStretcher, Patient Restraint

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZDStretcher, Patient RestraintGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057711230945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057711230945080577112309458057711230945

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
08057711237180SpencerSPENCER ITALIA SRLNZD2025-08-07
06974442054119RED LEAFJiangsu Rixin Medical Equipment Co.,LtdNZD2025-05-22
08057711230204SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230259SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230266SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230297SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230303SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230310SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230327SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230334SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230426SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230433SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230471SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230488SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711230525SpencerSPENCER ITALIA SRLNZD2023-10-26
08057711232994SpencerSPENCER ITALIA SRLNZD2023-10-26
00848340014338Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014345Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014352Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014369Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014376Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014383Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
00848340014437Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014335Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014342Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014359Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014366Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014373Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014380Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014434Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17