FDA.report

DEKNATEL

Primary DI
34026704634393
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN028776
Catalog number
X-4884
Device description
POLYDEK GREEN BRAIDED 2 SE-2 1N 30"
Published
2019-09-04
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
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications

CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704634393PackageGS136In Commercial Distribution
04026704427086PreviousGS10
14026704634399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670463439334026704634393
04026704427086040267044270864026704427086
1402670463439914026704634399

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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

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
false
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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