FDA.reportPublic FDA data

PrepEM Wild

Primary DI
06975675783302
Brand
PrepEM Wild
Company
EMSRUN GROUP
Model
Compressed gauze z-fold
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975675783302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975675783302069756757833026975675783302

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Regulatory Flags#

DUNS number
712452198
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
06975675788123Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
16975675788120Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
06975675781490PrepEM Wild18in splint2025-11-07
06975675781650PrepEM WildWound plaster/15pcs2025-11-07
06975675781667PrepEM WildNon-woven tape/2.5cm*5m2025-11-07
06975675781711PrepEM WildNitrile gloves/L2025-11-07
06975675781759PrepEM WildEmergency blanket/1.6*2.1m2025-11-07
06975675781773PrepEM WildScissors/16cm2025-11-07
06975675782091PrepEM WildPBT bandage/7.5cm*4.5m2025-11-07
06975675783074PrepEM WildWound compress/10*10cm/2pcs2025-11-07
06975675788499StBernardFirst aid kit/STIK00082025-11-07
06975675788505StBernardFirst aid kit/STIK00072025-11-07
06975675788512StBernardFirst aid kit/STIK00062025-11-07
06975675788529StBernardFirst aid kit/STIK00052025-11-07
06975675788536StBernardFirst aid kit/STIK00042025-11-07
06975675788543StBernardFirst aid kit/STIK00032025-11-07
06975675788574PrepEM WildAbdominal pad/12.7*23cm2025-11-07
06975675788581PrepEM WildDry burn dressing/40*60cm2025-11-07
06975675788789Rhino RescueFirst aid kit/CPIK0220/20L/Black2025-11-07
06975675788796Rhino RescueChest seal/CPXF0041/20pcs2025-11-07

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