FDA.reportPublic FDA data

Sof-Rol®

Primary DI
04042809667295
Brand
Sof-Rol®
Company
BSN MEDICAL, INC.
Model
72345-10
Device description
SOF-ROL STERILE 5CM X 3.6MTR 20
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBANDAGE, CAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809438468PrimaryGS10
04042809667295Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809438468040428094384684042809438468
04042809667295040428096672954042809667295

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool roll, sterileA device designed as an absorbent, sterile 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; it is not in the form of a bandage or dedicated dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length360Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags#

DUNS number
026301221
Device count
20
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
false
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
00035664600266JOBST Custom Seamed75074-0075074-002026-05-11
00035664600273JOBST Custom Seamed75074-0175074-012026-05-11
00035664600860JOBST Custom Seamed75065-0075065-002026-05-11
00035664600891JOBST Custom Seamed75066-0075066-002026-05-11
00035664601089JOBST Custom Seamed75067-0075067-002026-05-11
00035664601348JOBST Custom Seamed75064-0075064-002026-05-11
00035664601355JOBST Custom Seamed75064-0175064-012026-05-11
00035664601423JOBST Custom Seamed75071-0075071-002026-05-11
00035664601430JOBST Custom Seamed75071-0175071-012026-05-11
00035664601447JOBST Custom Seamed75071-0275071-022026-05-11
00035664601454JOBST Custom Seamed75072-0075072-002026-05-11
00035664601461JOBST Custom Seamed75071-0675071-062026-05-11
00035664601478JOBST Custom Seamed75071-0775071-072026-05-11
00035664601508JOBST Custom Seamed75071-0375071-032026-05-11
00035664601515JOBST Custom Seamed75071-0475071-042026-05-11
00035664601522JOBST Custom Seamed75071-0575071-052026-05-11
04042809633061JOBST Sport752896175289612018-06-30
04042809633146JOBST Sport752906175290612018-06-30
04042809649277ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818574ZONAS® by Actimove®65001-0165001-012025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998344046Solventum™Solventum Germany GmbHITG2026-09-24
00197998344060Solventum™Solventum Germany GmbHITG2026-09-24
00197998344084Solventum™Solventum Germany GmbHITG2026-09-24
00197998344107Solventum™Solventum Germany GmbHITG2026-09-24
00197998344121Solventum™Solventum Germany GmbHITG2026-09-24
007073874969683M™3M Deutschland GmbHITG2026-05-08
007073874969753M™3M Deutschland GmbHITG2026-05-08
007073874969823M™3M Deutschland GmbHITG2026-05-08
007073874969993M™3M Deutschland GmbHITG2026-05-08
087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529923M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530363M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530503M™ Scotchcast™Solventum US LLCITG2026-04-18
10080196284191MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10080196832330MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10192253045864WebrilCardinal Health 200, LLCITG2025-09-23
10192253045871WebrilCardinal Health 200, LLCITG2025-09-23
10192253045888WebrilCardinal Health 200, LLCITG2025-09-23
10192253045925WebrilCardinal Health 200, LLCITG2025-09-23
00840117344396"CurPro Undercast Padding , 100% Polyester, 3"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344402"CurPro Undercast Padding, 100% Polyester, 4"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344419"CurPro Undercast Padding, 100% Polyester, 6"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344426"CurPro Undercast Padding, 100% Polyester, 8"" x 4 yd"Dynarex CorporationITG2025-06-05
10885632106545MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-16
10885632106514MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10885632106538MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10197106823019CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
10080196745616MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196745661MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13