FDA.reportPublic FDA data

PureLife+ Cotton Tip Applicators

Primary DI
D79011132011
Brand
PureLife+ Cotton Tip Applicators
Company
PURELIFE, LLC
Model
1113201
Catalog number
1113201
Device description
"PureLife+ Cotton Tip Applicators, 3"", Non-sterile cotton tip applicators, Available in 3"" or 6"" ,"
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79011132011PrimaryHIBCC0
D79011132010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cotton rollA non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)777-3303sales@purelifedental.com

Regulatory Flags#

DUNS number
828690904
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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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