FDA.reportPublic FDA data

Simplastic

Primary DI
H66809216710
Brand
Simplastic
Company
Keystone Industries
Model
0921671
Catalog number
0921671
Device description
SIMPLASTIC SLEEVE (2000)- Barrier Item
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, operative dental, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66809216711PrimaryHIBCC0
H66809216710Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags#

DUNS number
073503117
Device count
2000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H66842201141HeyGears422011442201142023-02-20
H66842201151KeySplint Soft for HeyGears422011542201152021-07-06
H66850524011Nexa3D425020542502052023-02-20
H66852233011Nexa3D425020442502042023-02-20
H6682030051iSmile070137707013772023-02-20
H66807003771Seity070037707003772016-09-15
H66807021771M&S070217707021772017-10-11
H66807027771Seity070277707027772016-10-26
H66842204400Carbon 422044042304402025-08-28
H66842204410Carbon 422044142304412025-08-28
H66842204420Carbon 422044242304422025-08-28
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H668166361BOSWORTH16636166362022-11-30
H668166961BOSWORTH16696166962022-11-30
H66811475771Keystone Industries114757711475772022-11-30
H66811475781Keystone Industries114757811475782022-11-30
H668166301BOSWORTH16630166302022-11-30
H668166321BOSWORTH16632166322022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08
00840456223284JMUJMU DENTAL, INCNRD2026-07-08
00840456223291JMUJMU DENTAL, INCNRD2026-07-08
00840456223314JMUJMU DENTAL, INCNRD2026-07-08
D832MTXA15021PlasdentPLASDENT CORPORATIONNRD2026-06-04
D832MTXA15031PlasdentPLASDENT CORPORATIONNRD2026-06-04
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
D678AS50X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
TQ26126171011Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263511Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26126152121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152131Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152151Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152171Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152421Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09