FDA.reportPublic FDA data

First Aid Dressing M Compress 8cm x 10cm

Primary DI
04007418922104
Brand
First Aid Dressing M Compress 8cm x 10cm
Company
Hans Hepp GmbH & Co. KG
Model
92210
Device description
A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04007418922104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04007418922104040074189221044007418922104

GMDN Terms#

Term, Definition table
TermDefinition
First aid absorbent pad/bandageA wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315896217
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04007418924016Disposable Gloves Size L924012023-08-11
04007418924023Disposable Gloves Size L924022023-08-11
04007418924511Disposable Gloves Size L924012023-08-11
04007418924528Disposable Gloves Size L924022023-08-11
04007418891141Medical Face Mask891142023-07-28
04007418891158Medical Face Mask891152023-07-28
04007418914857Plaster Assortment914852023-07-25
04007418920704Wound Compresses 100mm x 100mm920702023-07-25
04007418920735Wound Compresses 100mm x 100mm920732023-07-25
04007418921404Triangular Bandage 96cm x 96cm x 136cm921402023-07-25
04007418921459Triangular Bandage 96cm x 96cm x 136cm921452023-07-25
04007418921732Elastic Bandage 6cm x 4m921732023-07-25
04007418921831Elastic Bandage 8cm x 4m921832023-07-25
04007418922005First Aid Dressing G Compress 10cm x 12cm922002023-07-25
04007418922036First Aid Dressing G Compress 10cm x 12cm922032023-07-25
04007418922203First Aid Dressing K Compress 6cm x 8cm922202023-07-25
04007418922234First Aid Dressing K Compress 6cm x 8cm922232023-07-25
04007418922531Bandaging Cloth A 600mm x 800mm922532023-07-25
04007418922555Bandaging Cloth A 600mm x 800mm922552023-07-25
04007418932806Adhesive Tape 5m x 2,5cm932802023-07-25

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