FDA.reportPublic FDA data

Elements by Hedy Barrier Envelopes

Primary DI
D903HEBEHO11
Brand
Elements by Hedy Barrier Envelopes
Company
Hedy Canada
Model
HE-BEHO1
Catalog number
HE-BEHO1
Device description
Dental Barrier Sleeves for Phosphor Storage, Size Medium
Published
2019-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
D903HEBEHO11PackageHIBCC100In Commercial Distribution
D903HEBEHO1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassette/storage phosphor screen, dentalA combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
249482399
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D903410MB2Hedy SoftMask410MB410MB2018-11-23
D903410MG2Hedy SoftMask410MG410MG2018-11-23
D903410MP2Hedy SoftMask410MP410MP2018-11-23
D903410MW2Hedy SofMask410MW410MW2018-11-23
D903420HFB2Hedy SoftMask420HFB420HFB2018-11-23
D903420HFG2Hedy SoftMask420HFG420HFG2018-11-23
D903420HFP2Hedy SoftMask420HFP420HFP2018-11-23
D903420HFW2Hedy SoftMask420HFW420HFW2018-11-23
D903420LFB2Hedy SoftMask420LFB420LFB2018-11-23
D903420LFG2Hedy SoftMask420LFG420LFG2018-11-23
D903420LFP2Hedy SoftMask420LFP420LFP2018-11-23
D903420LFW2Hedy SoftMask420LFW420LFW2018-11-23
D903430HVB2Hedy SoftMask430HVB430HVB2018-11-23
D903610HSP102HedySeal PRO Self-Sealing Sterilization Pouches 610HSP-10610HSP-102019-01-17
D903610HSP202HedySeal PRO Self-Sealing Sterilization Pouches610HSP-20610HSP-202019-01-17
D903610HSP302HedySeal PRO Self-Sealing Sterilization Pouches610HSP-30610HSP-302019-01-17
D903610HSP402HedySeal PRO Self-Sealing Sterilization Pouches610HSP-40610HSP-402019-01-17
D903610HSP502HedySeal PRO Self-Sealing Sterilization Pouches610HSP-50610HSP-502019-01-17
D903610HSP602HedySeal PRO Self-Sealing Sterilization Pouches610HSP-60610HSP-602019-01-17
D903HEBEHO21Elements by Hedy Barrier EnvelopesHE-BEHO2HE-BEHO22019-03-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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00618125190188VALOTIDI PRODUCTS, LLCPEM2025-08-29
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
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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