FDA.report

Deluxe Wound Closure Tray

Primary DI
00616784353432
Brand
Deluxe Wound Closure Tray
Company
DYNAREX CORPORATION
Model
3534
Device description
Deluxe Wound Closure Tray that contains: (1) One-compartment tray with TYVEK® lid; (1) Iris scissor; (1) Mosquito hemostat, curved, 5"; (1) Towel 18" x 17", 3 ply; (5) Gauze pad 4" x 4", 8 ply; (1) PVP swabsticks, 3 each; (1) Alcohol prep pad; (1) Poly bag (red) with twist tie; (1) Fenestrated drape, 26" x 18"; (1) Adson tissue forceps; (1) Needle holder, 5"
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDDKit, Surgical Instrument, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784353432PackageGS120In Commercial Distribution
00616784353425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353432006167843534326167843534320616784353432
00616784353425006167843534256167843534250616784353425

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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