FDA.reportPublic FDA data

PureLife Dental

Primary DI
D79010811040
Brand
PureLife Dental
Company
PURELIFE, LLC
Model
1081104
Catalog number
1081104
Device description
Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
Published
2020-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRUChair, Dental, Without Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79010811041PrimaryHIBCC0
D79010811040Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-777-3303Sales@PureLifeDental.com

Regulatory Flags#

DUNS number
828690904
Device count
1000
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
D79011549031PureLife Dental115490311549032025-07-08
D79011549033PureLife Dental115490311549032025-07-08
D790106840110685011PureOrthoSense10684011068501106840110685012025-03-20
D790106840210685021PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685031PureOrthoSense10684031068503106840310685032025-03-20
D790106840410685041PureOrthoSense10684041068504106840410685042025-03-20
D790106840510685051PureOrthoSense10684051068505106840510685052025-03-20
D790106840110685010PureOrthoSense10684011068501106840110685012025-03-20
D790106840210685020PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685030PureOrthoSense10684031068503106840310685032025-03-20
D790106840410685040PureOrthoSense10684041068504106840410685042025-03-20
D790106840510685050PureOrthoSense10684051068505106840510685052025-03-20
D79011130011PureLife+ Non-Woven Sponges111300111130012023-06-08
D79011130021PureLife+ Non-Woven Sponges111300211130022023-06-08
D79010811011PureLife Dental108110110811012020-05-13
D79010811021PureLife Dental108110210811022020-05-13
D79010811031PureLife Dental108110310811032020-05-13
D79010811041PureLife Dental108110410811042020-05-13
D79010840011PureLife+ Plastic Headrest Covers108400110840012023-06-08
D79010840021PureLife+ Plastic Headrest Covers108400210840022023-06-08

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Primary DI, Brand, Company table
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D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
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