FDA.reportPublic FDA data

Halyard

Primary DI
20885632243902
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
48533
Device description
NA
Published
2021-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
K180139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180139000Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd.2019-01-03FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632243902PackageGS18In Commercial Distribution
10885632243905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563224390220885632243902
1088563224390510885632243905

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid direct sunlight, Protect from water damage

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
false
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
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632524790SurgiTrackSM450087D8CD2026-06-25
10885632524721SurgiTrackSM450070DAF72026-06-24
10885632524738SurgiTrackSM450071932C2026-06-24
10885632523267SurgiTrackSM45008746332026-06-10
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04