FDA.reportPublic FDA data

Safco REPLACEMENT Face Shields-12 Pack

Primary DI
00856145008391
Brand
Safco REPLACEMENT Face Shields-12 Pack
Company
CLIKTECH LLC
Model
008-391
Catalog number
008-391
Device description
Safco REPLACEMENT Face Shields-12 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
00856145008391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856145008391008561450083918561450083910856145008391

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09