FDA.reportPublic FDA data

Cotton Roll

Primary DI
00616784325026
Brand
Cotton Roll
Company
Dynarex Corporation
Model
3250
Device description
Cotton Rolls #2 Medium
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

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
00616784325033PackageGS110In Commercial Distribution
00616784325026PrimaryGS10
00810180844185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784325033006167843250336167843250330616784325033
00616784325026006167843250266167843250260616784325026
00810180844185008101808441858101808441850810180844185

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool rollA device designed as an absorbent mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector or the home; it is not in the form of a bandage or dedicated dressing. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
2000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117307605Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3"106852021-04-22
00840117307629Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3"106862021-04-22
00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
00616784065311Ever-Soft Foam Cushion 20" x 16" x 3"106532021-04-22
00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
00840117307568Ever-Soft Coccyx Foam Cushion 18" x 16" x 3"106552021-04-22
00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

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