FDA.report

Devon

Primary DI
10884521145481
Brand
Devon
Company
Cardinal Health, Inc.
Model
50007067
Catalog number
50007067
Device description
7067 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

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884521145481PackageGS120In Commercial Distribution
20884521145488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452114548110884521145481
2088452114548820884521145488

GMDN Terms

TermDefinition
Suture kit, medicatedA collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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30884521012442Monoject888120231488812023142018-06-27
20884521012469Monoject888120232288812023222018-06-27
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20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

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