FDA.reportPublic FDA data

UnnaCare 4x6

Primary DI
00856525007907
Brand
UnnaCare 4x6
Company
SUN SCIENTIFIC, INC.
Model
ZO1050-01
Catalog number
UC6
Device description
"A 4"" x6""sterile or non sterile strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return).it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device."
Published
2023-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
00856525007907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856525007907008565250079078565250079070856525007907

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9144795108aalward@sun-scientific.com

Regulatory Flags#

DUNS number
609397224
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856525007082SunGauze, Gauze Dialysis Needle Dressing 60mm x 74mmPA1050-00SGP2021-07-21
00856525007068SunWrap Forearm U Bladder RightSW6280-00SW-FAUBR2021-05-10
00856525007235Rav Positioner Small2030SRAVP1000S2022-01-12
00856525007730Rav Positioner2030RAVP10002019-12-20
00856525007860Hip Off-Loader Assy, Medium FP7265 FP72652022-11-18
00856525007877Heel Off-Loader Assy, Medium HP7265 HP72652022-11-18
00856525007884SACRAL Off-Loader Assy, Medium SP7265 SP72652022-11-18
00856525007136SV BOLSTER MediumSP2355 SP23552022-04-26
00856525007143SV BOLSTER LARGESP2555 SP25552022-04-26
00856525007365PFAB SMALLPFAB-SPFAB-S2021-04-30
00856525007372PFAB MediumPFAB-MPFAB-M2021-04-30
00856525007389PFAB Medium CrescentPFAB-MCPFAB-MC2021-04-30
00856525007396PFAB LargePFAB-LPFAB-L2021-04-30
00850051939565AeroWrap™ Full LegFL-FL-SL-L-SF-SFL-FL-SL-L-SF-S2024-12-05
00850051939572AeroWrap™ Full LegFL-FL-SL-L-SF-MFL-FL-SL-L-SF-M2024-12-05
00850051939589AeroWrap™ Full LegFL-FL-SL-L-SF-LFL-FL-SL-L-SF-L2024-12-05
00850051939596AeroWrap™ Full LegFL-FL-SL-L-MF-SFL-FL-SL-L-MF-S2024-12-05
00850051939602AeroWrap™ Full LegFL-FL-SL-L-MF-MFL-FL-SL-L-MF-M2024-12-05
00850051939619AeroWrap™ Full LegFL-FL-SL-L-MF-LFL-FL-SL-L-MF-L2024-12-05
00850051939626AeroWrap™ Full LegFL-FL-SL-L-LF-SFL-FL-SL-L-LF-S2024-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
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
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
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
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
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