FDA.reportPublic FDA data

OPTICS ONE

Primary DI
00815384023282
Brand
OPTICS ONE
Company
MEDICAL TECHNIQUE, INC.
Model
MTI-4040
Catalog number
MTI-4040
Device description
Patient/OR Table Strap - 4 in wide
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00815384023282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815384023282008153840232828153840232820815384023282

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s) or band(s), 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. 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
520-733-7999INFO@MTIDRAPE.COM

Regulatory Flags#

DUNS number
790514756
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815384020670Medical Resources Group LimitedMRG100MRG1002021-09-27
10815384020677Medical Resources Group LimitedMRG100MRG1002021-09-27
00815384023237OPTICS ONEMTI-3030MTI-30302016-09-24
00815384023596OPTICS ONE4335-204335-202018-06-21
00815384020007OPTICS ONE1012-401012-402016-09-23
00815384020038OPTICS ONE1215-ZIP1215-ZIP2016-09-23
00815384020069OPTICS ONE1288-201288-202016-09-23
00815384020083OPTICS ONE1289-201289-202016-09-23
00815384020106OPTICS ONE1290-201290-202016-09-23
00815384020120OPTICS ONE1292-201292-202016-09-23
00815384020144OPTICS ONE1295-201295-202016-09-23
00815384020168OPTICS ONE272227222016-09-23
00815384020199OPTICS ONE3279-503279-502016-09-23
00815384020212OPTICS ONE4336-204336-202016-09-23
00815384020243OPTICS ONE4337-204337-202016-09-23
00815384020274OPTICS ONE4338-204338-202016-09-23
00815384020304OPTICS ONE4339-204339-202016-09-23
00815384020335OPTICS ONE4701-304701-302016-09-23
00815384020366OPTICS ONE4705-404705-402016-09-23
00815384020397OPTICS ONE4708-404708-402016-09-23

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
10848340014366Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014373Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17
10848340014380Patient RestraintADVANCE MEDICAL DESIGNS, INC.NZD2023-07-17