FDA.reportPublic FDA data

Medichoice

Primary DI
10885632130922
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
LAC1015
Device description
Laceration Tray MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632130920PackageGS124In Commercial Distribution
10885632130922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563213092050885632130920
1088563213092210885632130922

GMDN Terms#

Term, Definition table
TermDefinition
Wound closure set, topicalA collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00avoid freezing and excessive heat

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09
10198956258662CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956381131CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956299528CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-09
10198956308206CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-06
10198956254732CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
10198956369351CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956410817CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956377479CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
10198956318380CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
10198956325135CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
10198956252134CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956299979CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956285712CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
10198956249868CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956192966CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
10198956199620CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956279797CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956233522CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
10198956219205CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956223288CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956187450CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-03
10198956185128CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
10198956192881CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22