FDA.reportPublic FDA data

Isolator Disposable Cotton Roll Holder 50 Pack

Primary DI
00310866001470
Brand
Isolator Disposable Cotton Roll Holder 50 Pack
Company
PASCAL COMPANY, INC.
Model
28100
Catalog number
28-100
Device description
Plastic disposable cotton roll holder 50 pack.Each clamp firmly holds two cotton rolls, sizes 1,2 & 3.Provides a dry field without restricting access or visibility
Published
2019-07-09
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
EFNCotton, Roll

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310866001470PrimaryGS10
00310866002033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866001470003108660014703108660014700310866001470
00310866002033003108660020333108660020330310866002033

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
8004268051pascal@pascaldental.com

Regulatory Flags#

DUNS number
009260217
Device count
50
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310866000732Retrax Cord Cutter26440264402019-01-24
00310866002552KOIS KR-1 PACKER262252024-06-04
00310866002606KOIS KR-2 PACKER262262024-06-04
00310866002613KOIS KR-3 PACKER262272024-06-04
00310866002620KOIS KR-4 PACKER262282024-06-04
00310866002637KOIS KR-5 PACKER262292024-06-04
00310866002644GET SCULPTED26-31026-3102024-05-16
00310866002651Fluorilaq Salted Caramel (10mL) Tube104022024-03-28
00310866002668Fluorilaq Mint (10mL) Tube104062024-03-28
00310866002408Racord Plus Retraction Cord 7/0007797077972021-11-22
00310866002415Racord Plus Retraction Cord 8/007800078002021-11-22
00310866002422Racord Plus Retraction Cord 9/107810078102021-11-22
00310866002439Racord Plus Retraction Cord 10/207820078202021-11-22
00310866000800Retrax Pellets12400124002019-01-31
00310866000275KnitTrax Plain Retraction Cord 00007569075692019-01-29
00310866000282KnitTrax Plain Retraction Cord 0007570075702019-01-29
00310866000299KnitTrax Plain Retraction Cord 007575075752019-01-29
00310866000305KnitTrax Plain Retraction Cord 107580075802019-01-29
00310866000312KnitTrax Plain Retraction Cord 207585075852019-01-29
00310866000329SilTrax AS Retraction Cord 7/0007097070972019-01-24

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