FDA.reportPublic FDA data

Sensi-Wrap, Self Adherent

Primary DI
00616784329826
Brand
Sensi-Wrap, Self Adherent
Company
DYNAREX CORPORATION
Model
3298
Device description
Sensi-Wrap, Self Adherent, 3"x5yds Stretched, Purple
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

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
00616784329826PackageGS124In Commercial Distribution
00616784329819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784329826006167843298266167843298260616784329826
00616784329819006167843298196167843298190616784329819

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-useA strip or roll made of fabric with Hevea natural rubber latex (NRL) 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). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784124810Transducer Covers, For Ultrasound Imaging Systems, 5.3 cm x 20 cm12482016-09-24
00616784426211Piston Irrigation Syringe,Ring Top Syringe with Protective Cap Tubing Adaptor42622021-09-01
00616784020518Vivid-Essential Rollator with 6" Casters, Red102052019-10-07
00616784020617Vivid-Essential Rollator with 6" Casters, Blue102062019-10-07
00616784703015"IV Administration Set, 10 mL, Non-Toxic, 83"" "70302016-09-24
00616784703312"IV Administration Set, Non-Toxic, 15 mL, 106"" (269.2 cm)"70332016-09-24
00616784703411"IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)"70342016-09-24
00616784703718"IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)"70372016-09-24
00616784704814"IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) "70482016-09-24
00616784704913"IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)"70492016-09-24
00616784705118"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/ mL, 83"" (210.8 cm) "70512016-09-24
00616784705217"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/mL, 78"" (198.1 cm) "70522016-09-24
00616784705415Needleless PRN Luer Connectors, Non-Toxic70542016-09-24
00840117334502Pre-Filled Saline Flush Syringe, 5 mL70582024-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
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10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
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10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
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10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10097604110577Tronex International, Inc.TRONEX INTERNATIONAL, INC.FQM2025-05-05