FDA.reportPublic FDA data

Patient Restraint

Primary DI
00848340014369
Brand
Patient Restraint
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
A-30522-6
Device description
Disposable Patient Restraint
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10848340014366PackageGS18In Commercial Distribution
00848340014369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834001436610848340014366
00848340014369008483400143698483400143690848340014369

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb traction wrap/trap, single-useA preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848340018213Urological Drainage BagKTEK84112026-05-07
00848340018220Urological Drainage BagKYRA84102026-04-15
00848340018206Urological Drainage BagKTEK84102026-04-13
00848340010712C-FlexA-707022026-03-12
10848340010719C-FlexA-707022026-03-12
00848340014857Asonic GelASG-0012023-06-13
00848340002212Transducer Cover05-TC9962024-02-05
00848340002229Custom Cover08-CC1242024-02-06
00848340002236Custom Cover08-CC1342024-02-07
00848340002243Custom Cover08-CC1372024-02-07
00848340002250Custom Cover08-CC1392024-02-08
00848340002267Custom Cover08-CC1402024-02-08
00848340002281Camera Cover08-CC1492024-02-12
00848340002298Cassette Drape08-CC1502024-02-15
00848340002311Snap Kover08-CC1622024-02-15
00848340002328Custom Pack08-CC1632024-02-15
00848340002335Custom Pack08-CC1702024-02-20
00848340002342Positioning Arm Drape08-CU15612024-02-21
00848340002359Doppler Flow Wire CoverDFC1002024-03-13
00848340002366Doppler Flow Wire CoverDFC1012024-03-13

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
08057711230945SpencerSPENCER 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
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