FDA.reportPublic FDA data

Medichoice

Primary DI
10885632114359
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
LAC1011
Device description
Tray Laceration 2X2In 12Ply Gauze 4X4In 12Ply Gauze Blue Linen Operating Room Towel 18X26In Fenestrated Operating Room Towel Iris Scissor Straight 4.5In Adson Tissue Forcep 4.75In 1X2 Teeth Mosquito Halstead Curved 5In Webster Needle Holder Smooth 5In Lat
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50885632114357PackageGS120In Commercial Distribution
10885632114359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563211435750885632114357
1088563211435910885632114359

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
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18
10885632537110SurgiTrackSM450070CC682026-09-18
10885632532665SurgiTrackSM450087F5342026-09-04
10885632532726SurgiTrackSM450041DB622026-09-04
10885632531781SurgiTrackSM450071D8E02026-08-26
10885632531842SurgiTrackSM450059D7A22026-08-26
10885632531644SurgiTrackSM45008770E72026-08-25
10885632531361SurgiTrackSM450370A2B92026-08-21
10885632530845SurgiTrackSM4500879EF72026-08-19
10885632530852SurgiTrackSM4500874A9D2026-08-19
10885632530869SurgiTrackSM45008740342026-08-19
10885632530876SurgiTrackSM4500874A7F2026-08-19
10885632530883SurgiTrackSM450087A9BA2026-08-19
10885632530913SurgiTrackSM450087265F2026-08-19
10885632530135SurgiTrackSM4500454DAC2026-08-14
10885632530142SurgiTrackSM45037076DC2026-08-14
10885632530159SurgiTrackSM45037089B12026-08-14
10885632530166SurgiTrackSM45037046602026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538333HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538340HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538357HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538371HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538395HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538401HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538418HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538432HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538456HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538470HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538487HalyardAVID MEDICAL, INC.OVN2026-09-21
10809160538494HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160536902HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536940HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536971HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536988HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536995HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537060HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537145HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537152HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537169HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537176HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537183HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537190HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537206HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537213HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537220HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537237HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537244HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537251HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18