FDA.reportPublic FDA data

Safco PPE Face Shield System-6 Pack

Primary DI
00856145008384
Brand
Safco PPE Face Shield System-6 Pack
Company
CLIKTECH LLC
Model
008-384
Catalog number
008-384
Device description
Safco PPE Face Shield System- 6 Pack
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856145008384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856145008384008561450083848561450083840856145008384

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, reusableA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
044516217
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856200001138ClikRay Size 1 Sensor Cover 34mm/ 500 box001-138001-1382020-12-31
00856200001145ClikRay Size 1+2 Sensor Cover 36mm/ Box 500001-145001-1452020-12-31
00856200001152ClikRay Size 2 Sensor Cover 40mm/ Box 500001-152001-1522020-12-31
00856200001442ClikRay Green Line Universal Large Sensor Cover 40mm/500Box001-442001-4422020-12-31
00856200001763ClikRay Size I/O Camera Sleeves fits DexCam 3 - 500/BOX001-763001-7632020-12-31
00856145008001XL-Series Size 1 Anterior BLUE Bite Block 3-Pack008-001008-0012020-12-31
00856145008018XL-Series Size 1 Posterior YELLOW Bite Block 3-Pack008-018008-0182020-12-31
00856145008025XL-Series Size 1 Horizontal Bitewing DK ORANGE Bite Block 3-Pack008-025008-0252020-12-31
00856145008032XL-Series Size 1 Vertical Bitewing DK ORANGE Bite Block 3-Pack008-032008-0322020-12-31
00856145008049XL-Series Size 2 Anterior BLUE Bite Block 3-Pack008-049008-0492020-12-31
00856145008056XL-Series Size 2 Posterior YELLOW Bite Block 3-Pack008-056008-0562020-12-31
00856145008063XL-Series Size 2 Horizontal Bitewing DK ORANGE Bite Block 3-Pack008-063008-0632020-12-31
00856145008070XL-Series Size 2 Vertical Bitewing DK ORANGE Bite Block 3-Pack008-070008-0702020-12-31
00856145008087XL-Series Size 1 ShaRing Starter Kit008-087008-0872020-12-31
00856145008094XL-Series Size 2 ShaRing Starter Kit008-094008-0942020-12-31
00856145008100ClikStik, IRing, IRod, and 8 XL-Series Bite Blocks; Size 1&2008-100008-1002020-12-31
00856145008117ClikStik, IRing, IRod, and 8 Z-Series Bite Blocks; Size 1&2008-117008-1172020-12-31
00856145008124V-Series Size 2 Anterior WHITE Bite Block 3-Pack008-124008-1242020-12-31
00856145008131V-Series Size 2 Posterior WHITE Bite Block 3-Pack008-131008-1312020-12-31
00856145008148V-Series Size 2 Vertical Bitewing WHITE Bite Block 3-Pack008-148008-1482020-12-31

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