FDA.reportPublic FDA data

SRI Healthcare

Primary DI
00850057346046
Brand
SRI Healthcare
Company
Elevate Textiles, Inc.
Model
WRAP05405400-4-SV-0MDGN-0
Catalog number
4354
Device description
Wrapper, 54 x 54, Size 2XL, Green
Published
2024-04-08
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931874000RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USEAmsco Sterile Recoveries, Inc.1994-06-10FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057346046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057346046008500573460468500573460460850057346046

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. 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
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
00850057346145SRI HealthcareSHEET0540720-4-SV-0MDGN-00038732024-04-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
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