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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
00840456201947JMUJMU DENTAL, INCFRG2026-06-05
00840456202951JMUJMU DENTAL, INCFRG2026-06-05
00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05