FDA.reportPublic FDA data

Solventum™ Steri-Drape™

Primary DI
00197998343759
Brand
Solventum™ Steri-Drape™
Company
Solventum US LLC
Model
1015
Catalog number
1015
Device description
Solventum™ Steri-Drape™ U-Drape, 1015, 47 in x 51 in (120 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
00197998343766PackageGS14In Commercial Distribution
00197998343759PrimaryGS10
00197998343742Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998343766001979983437661979983437660197998343766
00197998343759001979983437591979983437590197998343759
00197998343742001979983437421979983437420197998343742

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
00197998040627Solventum™ Paradigm™5314S5314S2026-10-24
00197998040733Solventum™ Paradigm™5514S5514S2026-10-24
00197998041525Solventum™ Micropore™1533-01533-02026-10-23
00197998041556Solventum™ Micropore™1533-11533-12026-10-23
00197998042782Solventum™ Micropore™1530-01530-02026-10-23
00197998054129Solventum™ Micropore™1530-11530-12026-10-23
00197998054150Solventum™ Micropore™1530-21530-22026-10-23
00197998054181Solventum™ Micropore™1533-21533-22026-10-23
00197998054211Solventum™ Micropore™1530S-11530S-12026-10-23
00197998054242Solventum™ Micropore™1530-31530-32026-10-23
00197998040481Solventum™ Paradigm™531153112026-10-17
00197998040511Solventum™ Paradigm™531553152026-10-17
00197998040542Solventum™ Paradigm™5313J5313J2026-10-17
00197998040573Solventum™ Paradigm™531253122026-10-17
00197998040603Solventum™ Paradigm™531353132026-10-17
00197998040658Solventum™ Paradigm™551155112026-10-17
00197998040689Solventum™ Paradigm™551355132026-10-17
00197998040719Solventum™ Paradigm™5513J5513J2026-10-17
00197998040764Solventum™ Paradigm™551555152026-10-17
00197998189616Solventum™ Tegaderm™90212902122026-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618125192502Ziehm ImagingTIDI PRODUCTS, LLCPUI2026-10-22
08684382977444SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
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
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14