FDA.reportPublic FDA data

Foliodrape Protect Plus

Primary DI
04052199810195
Brand
Foliodrape Protect Plus
Company
PAUL HARTMANN AG
Model
936024 One Drape Solution Knee drape with 1 stocki
Catalog number
936024
Device description
One Drape Solution Knee drape with 1 stockinet, extra reinforced P10
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
04052199810201PackageGS110In Commercial Distribution
04052199810195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052199810201040521998102014052199810201
04052199810195040521998101954052199810195

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
04052199810157Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810171Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810164Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09

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Primary DI, Brand, Company table
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00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
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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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10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
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20748426264623Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
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