FDA.reportPublic FDA data

Devon

Primary DI
10884527007462
Brand
Devon
Company
Cardinal Health, Inc.
Model
50007065
Catalog number
50007065
Device description
7065 Laceration Tray
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527007462PackageGS120In Commercial Distribution
20884527007469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700746210884527007462
2088452700746920884527007469

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
true
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
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7403150031OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.KDD2026-03-20
00850074437048OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437109OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437116OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
50885380211193Aero-MedAERO-MED, LLCKDD2026-02-13
10653160392248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2026-02-11
07901125600584Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600591Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600607Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600614Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
50749756397808DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-01-22
10653160391302MedlineMEDLINE INDUSTRIES, INC.KDD2026-01-15
50885380206656Aero-MedAERO-MED, LLCKDD2026-01-15
00887868572524ToggleLoc™ WasherLoc™Biomet Orthopedics, LLCKDD2026-01-14
00850074437123OftalOnePackOFTAL-ONE INC.KDD2026-01-05
10653160390671Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2025-12-04
08800071700517TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
40198459450649MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459453510MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459454647MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459455231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459456238MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459697MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459765MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459888MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459460044MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459471767MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459473846MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459474669MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459476106MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18