FDA.report

ELASTOMULL

Primary DI
00035664048419
Brand
ELASTOMULL
Company
BSN MEDICAL, INC.
Model
02071001
Catalog number
02071001
Device description
ELASTOMULL STERILE 10CMX3.75M 12
Published
2020-07-28
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
FQMBANDAGE, ELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00035664048419PackageGS18In Commercial Distribution
00035664020712PrimaryGS10
00035664033279Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00035664048419000356640484190356640484190035664048419
00035664020712000356640207120356640207120035664020712
00035664033279000356640332790356640332790035664033279

GMDN Terms

TermDefinition
Pressure bandage, non-latex, sterileA sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Device Sizes

TypeValueUnit
Length375Centimeter
Width10Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags

DUNS number
026301221
Device count
12
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04042809841664JOBST forMen60520-0360520-032025-07-01
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04042809841688JOBST forMen60520-0560520-052025-07-01
04042809841695JOBST forMen60520-0660520-062025-07-01
04042809841701JOBST forMen60520-0760520-072025-07-01
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04042809841725JOBST forMen60520-0960520-092025-07-01
04042809841732JOBST forMen60520-1060520-102025-07-01
04042809841749JOBST forMen60520-1160520-112025-07-01
04042809841756JOBST forMen60532-0060532-002025-07-01
04042809841763JOBST forMen60532-0160532-012025-07-01

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