FDA.reportPublic FDA data

MICROTEK

Primary DI
30748426119029
Brand
MICROTEK
Company
Microtek Medical Inc.
Model
1
Device description
CLOSED SYSTEM CAMERA DRAPE W/2CM LENS, 1-EACH
Published
2016-12-27
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
KKXDrape, surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30748426119029PackageGS125In Commercial Distribution
50748426119023PackageGS11In Commercial Distribution
00748426119028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074842611902930748426119029
5074842611902350748426119023
00748426119028007484261190287484261190280748426119028

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

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
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
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
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
00812564036025MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036070MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036100MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036186MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036193MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036216MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036384MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10080196017010MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277636729MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660946MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10884389185780MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277635555MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10888277357037MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
16975424199276Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
10193489036954MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036961MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036978MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036985MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489040098MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
20885632426299HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426312HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426329HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426336HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426343HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426350HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426367HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426374HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30