FDA.reportPublic FDA data

Devon

Primary DI
10884521174917
Brand
Devon
Company
Cardinal Health, Inc.
Model
31141206
Catalog number
31141206
Device description
Absorbent Tray Liner
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K893764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893764000STERILIZATION TRAY LINERAhlstrom Dexter1989-08-15FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521174917PrimaryGS10
20884521174914Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452117491710884521174917
2088452117491420884521174914

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Regulatory Flags#

DUNS number
080935429
Device count
500
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24
10884521050792Argyle888856106888885610682016-09-24
10884521050808Argyle888856107688885610762016-10-06
10884521050815Argyle888857050788885705072016-09-24
10884521050822Argyle888857051588885705152016-09-24
10884521050839Argyle888857052388885705232016-09-24
10884521050846Argyle888857054988885705492016-09-24
10884521050853Argyle888857055688885705562016-09-24
10884521050877Argyle888857057288885705722016-09-24

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