FDA.reportPublic FDA data

VELYS™

Primary DI
10748426134813
Brand
VELYS™
Company
Microtek Medical Inc.
Model
Equipment Drapes
Catalog number
4516-11-019
Device description
VELYS™ Drape Robotic-Assist Station Touchscreen
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10748426134813PackageGS115In Commercial Distribution
20748426134810PackageGS12In Commercial Distribution
00748426134816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1074842613481310748426134813
2074842613481020748426134810
00748426134816007484261348167484261348160748426134816

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
106908437
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10748426134806VELYS™Equipment Drapes4516-11-0182025-01-24
10748426134820VELYS™Equipment Drapes4516-11-0202025-01-24
10748426137104MedtronicEquipment Drapes97327222024-11-05
10748426137111MedtronicEquipment Drapes97330232024-11-05
10748426137203Boston ScientificProbe Cover (BSC 3320)6633202024-10-22
50748426123976Zimmer BiometEquipment Drapes20-8020-080-002024-10-15
30748426123569Cardinal HealthOrgan Bag29-100392024-09-26
08425921000502MICROTEK12018-08-29
18425921000530MICROTEK12018-08-29
18425921000578MICROTEK12018-08-29
18425921000592MICROTEK12018-08-29
18425921000615MICROTEK12018-08-29
18425921000639MICROTEK12018-08-29
50748426130110DePuy Synthes VELYS4515700194515-70-0192023-03-09
30748426074946Microtek™9604UK9604UK2022-09-21
30748426132196CovidienPC-6X96PC-6X962022-08-16
30748426118527Skytron Lite-LokB1-020-99-2B1-020-99-22022-08-08
30748426118572Skytron ArgosB5-010-02-12022-08-08
08425921000038MICROTEK12018-08-29
18425921000059MICROTEK12018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
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