FDA.report

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

Related Records

Contact Domains

Product Codes

CodeName
ITGBANDAGE, CAST

Product Code Classifications

CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042809438468PrimaryGS10
04042809667295Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042809438468040428094384684042809438468
04042809667295040428096672954042809667295

GMDN Terms

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

TypeValueUnit
Length360Centimeter
Width5Centimeter

Sterilization Methods

Method

Contacts

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

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