FDA.report

Dressing Change Tray, Sterile

Primary DI
00616784470535
Brand
Dressing Change Tray, Sterile
Company
DYNAREX CORPORATION
Model
4705
Device description
Dressing Change Tray, Sterile: Instructions, Face Mask, Pair Vinyl Gloves with Wallet, Polylined Drape 13"x18", Tape Measure- 36", Pkg Alcohol Swabsticks (3/pkg), Pkg PVP Swabsticks (3/pkg), Non-woven Split Sponge 4"x4", Non-Adherent Sponge 2"x2", Gauze Sponge 4"x4", Roll Transparent Dressing Tape 3/4"x18", Transparent Dressing 4"x4 3/4", Dressing Change Label, Tray
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00616784470535PackageGS120In Commercial Distribution
00616784470528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784470535006167844705356167844705350616784470535
00616784470528006167844705286167844705280616784470528

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
false
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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