FDA.reportPublic FDA data

CONTEX LF ST 6X5 10/CS

Primary DI
10612553013320
Brand
CONTEX LF ST 6X5 10/CS
Company
PAUL HARTMANN AG
Model
50600000
Device description
CONTEX LF ST 6X5 10/CS
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
10612553013320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061255301332010612553013320

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315768788
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052199810164Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810188Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810201Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09
04052199777382Zetuvit Plus413600 Zetuvit Plus Shapes Oval4136002026-01-20
04052199777412Zetuvit Plus413601 Zetuvit Plus Shapes Heart Multisite P10 C64136012026-01-20
04052199777436Zetuvit Plus413602 Zetuvit Plus Shapes Multisite P10 C64136022026-01-20
04052199708935Zetuvit Plus413729 Zetuvit Plus 6 x 6 cm P104137292024-12-10
04052199708959Zetuvit Plus413739 Zetuvit Plus 20 x 60 cm P104137392024-12-10
04052199732404Atrauman Ag499606 Atrauman Ag USA st 5x5cm, P10499606 2025-03-19
04052199732442Atrauman Ag499607 Atrauman Ag USA st 10x10cm, P104996072025-03-19
04052199732473Atrauman Ag499608 Atrauman Ag USA st 10x20cm, P104996082025-03-19
20612553013440AC TAPE PLUS 2X5 72/CS64210000 AC TAPE PLUS 2X5 72/CS642100002020-09-01
04052199571331Hydrofilm 6x7cm sterile New P1009700012023-05-17
04052199571393Hydrofilm 6x7cm sterile P109700002023-05-17
04052199571423Hydrofilm 15x20cm sterile P509700072023-05-17
04052199571461Hydrofilm 20x30cm sterile P109700102023-05-17
04052199571508Hydrofilm 10x15cm sterile P509700052023-05-17
04052199571546Hydrofilm 10x12,5cm sterile P1009700032023-05-17
04052199571577Hydrofilm 10x12,5cm sterile P109700022023-05-17
04052199571607Hydrofilm 10x15cm sterile P109700042023-05-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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26975803530802GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530819GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
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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