FDA.reportPublic FDA data

SRI Healthcare

Primary DI
00850057346121
Brand
SRI Healthcare
Company
Elevate Textiles, Inc.
Model
SHEET0420540-4-SV-0MDGN-000
Catalog number
3871
Device description
Sheet, Level 4 medium
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080796000SRI LP DRAPESri/Surgical Express2008-11-17KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057346121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057346121008500573461218500573461210850057346121

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
13366841683nathaniel.terry@elevatetextiles.com

Regulatory Flags#

DUNS number
825198484
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057346015SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0SM74012024-04-08
00850057346022SRI HealthcareWRAP03603600-4-SV-0MDGN-043002024-04-08
00850057346039SRI HealthcareWRAP04804800-4-SV-0MDGN-043502024-04-08
00850057346046SRI HealthcareWRAP05405400-4-SV-0MDGN-043542024-04-08
00850057346053SRI HealthcareWRAP05307200-4-SV-0MDGN-043602024-04-08
00850057346237SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0SM78012024-04-08
00850057346244SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0MD78022024-04-08
00850057346251SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0LG78032024-04-08
00850057346268SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-0XL78042024-04-08
00850057346275SRI HealthcarePREMSRGWNXLT04-SV-0MDGN-2XL78052024-04-08
00850057346282SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0MD74022024-04-08
00850057346305SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-0XL74042024-04-08
00850057346312SRI HealthcarePREMSRGWNXLT-03-SV-0MDGN-2XL74052024-04-08
00850057346336SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0MD70022024-04-08
00850057346343SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0LG70032024-04-08
00850057346350SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-0XL70042024-04-08
00850057346367SRI HealthcareSURGWNMAXPRO-02-SV-0MDGN-2XL70052024-04-08
00850057346381Burlington IndustriesSURGWNMAXULT03-SV-0115F-0MD79022024-04-08
00850057346411Burlington IndustriesSURGWNMAXULT03-SV-0115F-2XL79052024-04-08
00850057346091SRI HealthcareDRAPE0721050-4-SV-0MDGN-00030462024-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
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20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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