FDA.reportPublic FDA data

Solventum™ Steri-Drape™

Primary DI
00197998329678
Brand
Solventum™ Steri-Drape™
Company
Solventum US LLC
Model
1060
Catalog number
1060
Device description
Solventum™ Steri-Drape™ Isolation Drape with Incise Film, 1060, 51 in x 51 in (130 cm x 130 cm), 10/CAR, 4 CAR/CS, 40/CS
Published
2026-08-23
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

Contact Domains#

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
00197998329685PackageGS14In Commercial Distribution
00197998329678PrimaryGS10
00197998329661Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998329685001979983296851979983296850197998329685
00197998329678001979983296781979983296780197998329678
00197998329661001979983296611979983296610197998329661

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001277Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001369Solventum™ Tegaderm™166416642026-08-23
00197998002861Solventum™ Tegaderm™9132NS9132NS2026-08-23
00197998149016Solventum™ Tegaderm™358435842026-08-23
00197998149047Solventum™ Tegaderm™358235822026-08-23
00197998149078Solventum™ Tegaderm™358735872026-08-23
00197998149382Solventum™ Tegaderm™358635862026-08-23
00197998149412Solventum™ Tegaderm™359335932026-08-23
00197998149443Solventum™ Tegaderm™359035902026-08-23
00197998149474Solventum™ Tegaderm™358835882026-08-23
00197998149504Solventum™ Tegaderm™358935892026-08-23
00197998150340Solventum™ Clinpro™7200M7200M2026-08-23
00197998150371Solventum™ Clinpro™7200W7200W2026-08-23
00197998150401Solventum™ Clinpro™7200FF7200FF2026-08-23
00197998150432Solventum™ Clinpro™7210M7210M2026-08-23
00197998150463Solventum™ Clinpro™7210W7210W2026-08-23
00197998150494Solventum™ Clinpro™7210FF7210FF2026-08-23
00197998150517Solventum™ Clinpro™7220SP7220SP2026-08-23
00197998173523Solventum™ Tegaderm™912491242026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305016Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305030Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305078Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305092Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305115Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305139Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312373Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329791Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329821Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329852Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330032Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330124Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330216Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330278Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330308Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330346Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330360Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330438Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330520Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23