FDA.reportPublic FDA data

MICROTEK

Primary DI
50748426090841
Brand
MICROTEK
Company
Microtek Medical Inc.
Model
1
Device description
UNIVERSAL LENS HOOD
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50748426090841PackageGS124In Commercial Distribution
00748426090846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074842609084150748426090841
00748426090846007484260908467484260908460748426090846

GMDN Terms#

Term, Definition table
TermDefinition
Surgical helmetA device worn by operating room personnel (the surgeon or assisting doctors/nurses) during a surgical procedure to protect them from the transfer of microorganisms, body fluids, and particulate material which may inadvertently come into contact or splash into their face. It is typically composed of a helmet frame with a transparent Plexiglas face shield. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under normal warehouse conditions.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags#

DUNS number
106908437
Device count
1
DM exempt
false
Premarket exempt
false
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
10748426134806VELYS™Equipment Drapes4516-11-0182025-01-24
10748426134813VELYS™Equipment Drapes4516-11-0192025-01-24
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
50748426113748EcolabCoreTemp EquipmentCTW5L2023-11-30
50748426126731EcolabHush Slush EquipmentESW7L2023-11-16
08425921000502MICROTEK12018-08-29
18425921000530MICROTEK12018-08-29
18425921000578MICROTEK12018-08-29
18425921000592MICROTEK12018-08-29
18425921000615MICROTEK12018-08-29
18425921000639MICROTEK12018-08-29
00748426130092DePuy Synthes VELYS4515700184515-70-0182023-03-09
50748426130110DePuy Synthes VELYS4515700194515-70-0192023-03-09
30748426074946Microtek™9604UK9604UK2022-09-21
30748426132196CovidienPC-6X96PC-6X962022-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634916349740Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788105Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788112Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788129Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789249ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789256ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789263ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916792775OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796322ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796339ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796346ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916829358ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880205ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880816ComPel Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880823ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916899627ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
10888277720053MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
10888277419872MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277419889MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277660908MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674707MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674714MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674721MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674738MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10193489021820MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
10193489040111MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
10197344014002MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
06931747835652ZDXuchang Zhengde Environstar Medical Products Co., Ltd.FYA2026-02-01
20197344179760MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-01-29
00850078013002MAXAIRSyntech, Int'l Inc.FYA2026-01-14