FDA.reportPublic FDA data

SRI Healthcare

Primary DI
00850057346053
Brand
SRI Healthcare
Company
Elevate Textiles, Inc.
Model
WRAP05307200-4-SV-0MDGN-0
Catalog number
4360
Device description
Wrapper, 53 x 72, Size Large, 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
00850057346053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057346053008500573460538500573460530850057346053

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
00850057346046SRI HealthcareWRAP05405400-4-SV-0MDGN-043542024-04-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
00859464007748Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061875MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061899MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061905MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061929MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
00850072625867Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572025Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572032Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572049Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572070Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04