FDA.reportPublic FDA data

ELASTOMULL

Primary DI
00035664048402
Brand
ELASTOMULL
Company
BSN MEDICAL, INC.
Model
02070001
Catalog number
02070001
Device description
ELASTOMULL STERILE 7.6CMX3.75M 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00035664048402PackageGS18In Commercial Distribution
00035664020705PrimaryGS10
00035664033262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00035664048402000356640484020356640484020035664048402
00035664020705000356640207050356640207050035664020705
00035664033262000356640332620356640332620035664033262

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length375Centimeter
Width7.6Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042809649796ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818581ZONAS® by Actimove®65001-0165001-012025-09-02
04042809662764JOBST forMen60520-0060520-002025-07-01
04042809663143JOBST forMen60520-0160520-012025-07-01
04042809687828JOBST forMen60520-2060520-202025-07-01
04042809702033JOBST forMen60422-0360422-032025-07-01
04042809702040JOBST forMen60422-0560422-052025-07-01
04042809702057JOBST forMen60422-0660422-062025-07-01
04042809841657JOBST forMen60520-0260520-022025-07-01
04042809841664JOBST forMen60520-0360520-032025-07-01
04042809841671JOBST forMen60520-0460520-042025-07-01
04042809841688JOBST forMen60520-0560520-052025-07-01
04042809841695JOBST forMen60520-0660520-062025-07-01
04042809841701JOBST forMen60520-0760520-072025-07-01
04042809841718JOBST forMen60520-0860520-082025-07-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178881192Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178881208Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178884599ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884605ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884612ViveCareVIVE HEALTH LLCFQM2026-02-05
08809302580652New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580683New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580928New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580874New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587538Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587545Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587552Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587569Soosung Elastic Bandagesoosung medicalFQM2025-12-11
00029369186019McDavidDoctor Shock IncFQM2025-12-01
00029369186026McDavidDoctor Shock IncFQM2025-12-01
26975803530802GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530819GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530826GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530833GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530840GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530857GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530864GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
16975803530874GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
30840330705869ProCureTwin Med, LLCFQM2025-11-26
30840330705876ProCureTwin Med, LLCFQM2025-11-26
30840330705883ProCureTwin Med, LLCFQM2025-11-26
04250381827123Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827130Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827147Elastic head bandage with ear slipSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15