FDA.reportPublic FDA data

OPTICS ONE

Primary DI
00815384023596
Brand
OPTICS ONE
Company
MEDICAL TECHNIQUE, INC.
Model
4335-20
Catalog number
4335-20
Device description
Mini C-arm Drape Kit 46 x 72
Published
2018-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815384023602PackageGS110In Commercial Distribution
00815384023619PackageGS12In Commercial Distribution
00815384023596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815384023602008153840236028153840236020815384023602
00815384023619008153840236198153840236190815384023619
00815384023596008153840235968153840235960815384023596

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
790514756
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
00815384023282OPTICS ONEMTI-4040MTI-40402016-09-24
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
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12