FDA.reportPublic FDA data

"SCOTT'S HALF CHAIR CVR 27.5"" X 24"" (225/bx)"

Primary DI
D77810750091
Brand
"SCOTT'S HALF CHAIR CVR 27.5"" X 24"" (225/bx)"
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
107-5009
Catalog number
107-5009
Device description
"CHAIR COVERS (225/box) Dimensions: 27-1/2"" x 24"", Color: Clear, Covers: Half Chair; For more information: https://www.scottsdental.com/catalog/product/view/id/24005/s/chair-covers-scott-s-select/"
Published
2021-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEMDental barriers and sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77810750091PrimaryHIBCC0
D77810750090Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags#

DUNS number
137217043
Device count
225
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D77819910111SCOTT'S SELECT 37% ETCH GEL 1.2ml SYRINGE KIT 4/pk199-1011199-10112017-05-24
D77819910121SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT199-1012199-10122017-05-24
D77819910131SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE KIT199-1013199-10132017-05-24
D77819910141SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE199-1014199-10142017-05-24
D77819910081SCOTT'S SELECT AUTOMIX 25ml TEMP CEMENT NE199-1008199-10082017-06-02
D77819910451SCOTT'S SELECT TEMP AUTOMIX NE 11gm199-1045199-10452017-06-02
D77818810880SCOTT'S MORREL CROWN REMOVER w/ 4-TIPS188-1088188-10882021-02-27
D77818820080SCOTT'S CROWN GRABBER REMOVER188-2008188-20082021-02-27
D77818831030SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS188-3103188-31032021-02-27
D77810702991Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704441Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810320011Scott's Select Mirror Handle Cone Socket Octagonal103-2001103-20012024-09-05
D77810320021Scott's Select Mirror Handle Cone Socket Round103-2002103-20022024-09-05
D77810320031Scott's Select Mouth Mirror Front Surface #3103-2003103-20032024-09-05
D77810320041Scott's Select Mouth Mirror Front Surface #4103-2004103-20042024-09-05
D77810320051Scott's Select Mouth Mirror Front Surface #5103-2005103-20052024-09-05
D77810750051"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) CLEAR"107-5005107-50052021-02-27
D77810750061"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) BLUE"107-5006107-50062021-02-27
D77810750071"SCOTT'S FULL CHAIR COVER 29"" X 80"" (125/bx)"107-5007107-50072021-02-27
D77810750111"SCOTT'S HEADREST CVR STD 9.5"" X 11"" (250)"107-5011107-50112021-02-27

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00618125188710VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188727VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188734VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125189953VALOTIDI PRODUCTS, LLCPEM2025-08-29
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00816577024581Young InfinityYoung Innovations, Inc.PEM2024-09-30
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00816577024611DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024628DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024635DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
20850061028024Dental BasicsDental Basics Inc.PEM2024-05-08
10371347011941Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10371347011958Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
00816419021617iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021624iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021853iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021860iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021877iSmileIsmile Dental Products, Inc.PEM2023-06-21