FDA.report

DEKNATEL

Primary DI
44026704559631
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN025267
Catalog number
RC-1040
Device description
RC TIE PAK TEV X1 SLK X2
Published
2015-10-16
Public version status
Update
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
24026704559651PackageGS11In Commercial Distribution
44026704559631PackageGS16In Commercial Distribution
04026704559657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670455965124026704559651
4402670455963144026704559631
04026704559657040267045596574026704559657

GMDN Terms

TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length75Centimeter

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
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
true
Sterilization required before use
false

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