FDA.reportPublic FDA data

Foliodrape Protect Plus

Primary DI
04052199810157
Brand
Foliodrape Protect Plus
Company
PAUL HARTMANN AG
Model
936022 Foliodrape Protect Plus One Drape Solution
Catalog number
936022
Device description
Foliodrape Protect Plus One Drape Solution Hip drape with 2 stockinets, extra reinforced P5
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052199810164PackageGS15In Commercial Distribution
04052199810157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052199810164040521998101644052199810164
04052199810157040521998101574052199810157

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Regulatory Flags#

DUNS number
315768788
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049500834919HydroTac transparent 5cmx7,5cm st P10685900 HydroTac transparent 5cmx7,5cm st P106859002020-09-01
04049500834940HydroTac transparent 10cmx10cm st P10685901 HydroTac transparent 10cmx10cm st P106859012020-09-01
04049500834971HydroTac transparent 10x20cm st P10 C6685902 HydroTac transparent 10x20cm st P10 C66859022020-09-01
04049500835008HydroTac transparent 20x20cm st P10685903 HydroTac transparent 20x20cm st P106859032020-09-01
04049500835039HydroTac transparent comf. 8x8cm st P10685920 HydroTac transparent comf. 8x8cm st P106859202020-09-01
04049500835091HydroTac transp. comf. 10x20cm st P10685922 HydroTac transp. comf. 10x20cm st P106859222020-09-01
04049500835121HydroTac transp. comf. 6,5x10cm st P10685923 HydroTac transp. comf. 6,5x10cm st P106859232020-09-01
04052199273501HydroTac transparent 5x7,5cm steril P10685905 HydroTac transparent 5x7,5cm steril P102020-09-01
04052199273563HydroTac transp. comfort 8x8cm st P10685925 HydroTac transp. comfort 8x8cm st P102020-09-01
04052199273600HydroTac transp. comf.12,5x12,5cm st P10685926 HydroTac transp. comf.12,5x12,5cm st P102020-09-01
04052199273648HydroTac transp. comf. 10x20cm st P10685927 HydroTac transp. comf. 10x20cm st P102020-09-01
04052199273686HydroTac transp. comf. 6,5x10cm st P10685928 HydroTac transp. comf. 6,5x10cm st P102020-09-01
04052199274201HydroTac transparent 10x10cm steril P10685906 HydroTac transparent 10x10cm steril P102020-09-01
04052199274249HydroTac transparent 10x20cm steril P10685907 HydroTac transparent 10x20cm steril P102020-09-01
04052199274287HydroTac transparent 20x20cm steril P10685908 HydroTac transparent 20x20cm steril P102020-09-01
04049500835060HydroTac transp.comf. 12,5x12,5cm st P10685921 HydroTac transp.comf. 12,5x12,5cm st P106859212020-09-01
04052199807188Zetuvit Plus413926 Zetuvit Plus Shapes Oval4139262026-09-28
04052199810171Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810195Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09
04052199810164Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
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20748426264623Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20888277636597MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
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