FDA.reportPublic FDA data

Disposa-Shield®

Primary DI
D0039078911
Brand
Disposa-Shield®
Company
Dentsply Professional
Model
90789-1
Device description
Disposa-Shield® Disposable Barrier Trial Pack For Cordless Prophy System Inner Module Contains: 25 Disposable Polyethylene Barriers
Published
2017-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D0039078911PrimaryHIBCC0
D0039078910Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, non-sterileA non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
144140845
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0013032800Ceramco 33032803032802026-02-20
D0013031901Ceramco 33031903031902024-10-02
D0013032801Ceramco 33032803032802024-10-02
D0013034001Ceramco 33034003034002024-10-02
D0013034601Ceramco 33034603034602024-10-02
D0013035601Ceramco 33035603035602024-10-03
D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
D0013038401Ceramco 33038403038402024-10-03
D0013039201Ceramco 33039203039202024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02
D0013051211Ceramco 33051213051212024-10-03
D0013051321Ceramco 33051323051322024-10-02
D0013051331Ceramco 33051333051332024-10-02
D0013051371Ceramco 33051373051372024-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187140VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188710VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188727VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188734VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125189953VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190171VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190188VALOTIDI PRODUCTS, LLCPEM2025-08-29
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02
00816577024581Young InfinityYoung Innovations, Inc.PEM2024-09-30
00816577024604DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
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