FDA.reportPublic FDA data

OPTICS ONE

Primary DI
00815384023220
Brand
OPTICS ONE
Company
MEDICAL TECHNIQUE, INC.
Model
MTI-2500
Catalog number
MTI-2500
Device description
Armboard Straps 1 x 30
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00815384023220PackageGS110In Commercial Distribution
00815384023213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815384023220008153840232208153840232200815384023220
00815384023213008153840232138153840232130815384023213

GMDN Terms#

Term, Definition table
TermDefinition
Arm restraintA non-rigid device, typically a strap or band made of various materials (e.g., fabric, nylon, leather, foam), used to temporarily secure a patient's arm(s) to a fixture or furniture part (e.g., bedrail, chair, table leg) to restrict the patient's physical activity for the prevention of potential injury or hazards. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790514756
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00815384023282OPTICS ONEMTI-4040MTI-40402016-09-24
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

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