FDA.report

DEKNATEL

Primary DI
34026704555384
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN026647
Catalog number
V-3813
Device description
V-PAK (X7-6803GWM7)X1 (X7-6803GWM8)X1
Published
2018-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OVNSuture kit

Product Code Classifications

CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704555384PackageGS16In Commercial Distribution
04026704555383PreviousGS10
14026704555380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670455538434026704555384
04026704555383040267045553834026704555383
1402670455538014026704555380

GMDN Terms

TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length48Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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