FDA.reportPublic FDA data

Medline

Primary DI
10888277563889
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SVI-1050
Catalog number
SVI-1050
Device description
DRAPE MRI PATIENT
Published
2021-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKKSUDAN IV

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKKSudan IvHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277563880PackageGS120In Commercial Distribution
10888277563889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827756388040888277563880
1088827756388910888277563889

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)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336101012Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108813Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108998Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336114630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108810Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336114637Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00840216101784ASP Medical Asp Global, LLCKKK2022-08-02
10840216101781ASP Medical Asp Global, LLCKKK2022-08-02
10634916809401Side DrapeSTANDARD TEXTILE CO., INC.KKK2021-06-11
40888277563880MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
10080196895410MedlineMEDLINE INDUSTRIES, INC.KKK2021-01-26
10080196747924MedlineMEDLINE INDUSTRIES, INC.KKK2020-12-17
00851354004264Sterile DrapeAVINGER, INC.KKK2019-03-21
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2017-03-02
10080196308200MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196722938MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196915033MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
40080196308201MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
00801902081490ARROWTELEFLEX INCORPORATEDKKK2016-09-16
30801902081491ARROWTELEFLEX INCORPORATEDKKK2016-09-16
20845225012681SpinVision STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2016-09-08
10845225012707R-100 STERILE EQUIPMENT COVERPhilips Image Guided Therapy CorporationKKK2016-09-08
10885380064234CONVERTORSCardinal Health 200, LLCKKK2016-06-28
50885380064232CONVERTORSCardinal Health 200, LLCKKK2016-06-28