FDA.report

Health-Tec/DHP Barrier Products

Primary DI
D773660HT101421
Brand
Health-Tec/DHP Barrier Products
Company
Dental Health Products Inc
Model
660-HT10142
Catalog number
660-HT10142
Device description
Health-Tec/DHP Tray Sleeves 10.5" x 14" 500/box
Published
2022-10-20
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

Related Records

Product Codes

CodeName
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773660HT101421PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
623191194
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
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
D7735901000721DHP/Health-Tec Sterilization Tape 590-100072590-1000722023-03-24
D7735901000821DHP/Health-Tec Sterilization Tape590-100082590-1000822023-03-24
D7736001000320DHP/Health-Tec Sterilization Pouches600-100032600-1000322023-03-23
D7736001000420DHP/Health-Tec Sterilization Pouches600-100042600-1000422023-03-23
D7736001000520DHP/Health-Tec Sterilization Pouches600-100052600-1000522023-03-23
D7736001000620DHP/Health-Tec Sterilization Pouches600-100062600-1000622023-03-23
D7736001000720DHP/Health-Tec Sterilization Pouches600-100072600-1000722023-03-23
D7736001000820DHP/Health-Tec Sterilization Pouches600-100082600-1000822023-03-23
D7736001000920DHP/Health-Tec Sterilization Pouches600-100092600-1000922023-03-23
D7736001001020DHP/Health-Tec Sterilization Pouches600-100102600-1001022023-03-23
D7736001001120DHP/Health-Tec Sterilization Pouches600-100112600-1001122023-03-23
D773970100010Health-Tec/DHP Disposable Prophy Angles970-10001970-100012022-11-28
D773970100020Health-Tec/DHP Disposable Prophy Angles970-10002970-100022022-11-28
D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
D7739705224140Health-Tec/DHP Disposable Prophy Angles970-522414970-5224142022-11-28
D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
D773930100060Health-Tec/DHP PSP Barrier Envelopes930-10006930-100062022-11-14
D773930HTBWT0Health-Tec/DHP Bite Wing Tabs930-HTBWT930-HTBWT2022-11-14
D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

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