FDA.reportPublic FDA data

ESMARK 3X9 ST 20/CS

Primary DI
40612553014533
Brand
ESMARK 3X9 ST 20/CS
Company
PAUL HARTMANN AG
Model
18310000
Device description
ESMARK 3X9 ST 20/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
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612553014533PackageGS120In Commercial Distribution
10612553014532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061255301453340612553014533
1061255301453210612553014532

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
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00840490800007PRESTIGEPROPRESTIGE AMERITECH, LTD.GAX2025-04-04
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