FDA.report

ESMARK 6X9 ST 20/CS

Primary DI
40612553014571
Brand
ESMARK 6X9 ST 20/CS
Company
PAUL HARTMANN AG
Model
18610000
Device description
ESMARK 6X9 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

Related Records

Product Codes

CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications

CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40612553014571PackageGS120In Commercial Distribution
10612553014570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4061255301457140612553014571
1061255301457010612553014570

GMDN Terms

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

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

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04052199732404Atrauman Ag499606 Atrauman Ag USA st 5x5cm, P10499606 2025-03-19
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