FDA.reportPublic FDA data

PureLife+ Cotton Rolls

Primary DI
D79011131010
Brand
PureLife+ Cotton Rolls
Company
PURELIFE, LLC
Model
1113101
Catalog number
1113101
Device description
PureLife+ Cotton Rolls, #2 Medium, Non-sterile, soft cotton rolls, Made from 100% cotton; no cellulose or rayon fibers and lint-free, Absorb up to 10 times their weight and maintains their shape when wet, #2 Medium (3/8" x 1 1/2")
Published
2023-06-08
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
EFNCOTTON, ROLL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79011131011PrimaryHIBCC0
D79011131010Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828690904
Device count
2000
DM exempt
false
Premarket exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194401657AiraAIRA, LLCEFN2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
50732224001086Ultra Gauze Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2025-10-23
00810124531843Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-09-03
00810132808203House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
00810132044281HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
00810132044274HCSConcordance Healthcare Solutions LLCEFN2025-03-05
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701991Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184810Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10850053289535SURGYCOSurgyco LLCEFN2024-08-09
10850053289542SURGYCOSurgyco LLCEFN2024-08-09
00850053289538SURGYCOSurgyco LLCEFN2024-08-09