FDA.reportPublic FDA data

Patient Restraint

Primary DI
10848340014366
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
Rx
false
OTC
false
Sterile
false
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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
10848340014373Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014380Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014434Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17