FDA.reportPublic FDA data

DEKNATEL

Primary DI
04026704421961
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN010283
Catalog number
89-5037W
Device description
CTY WH TP 3MM KC-25 2N 18
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCATAPE, SURGICAL, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCATape, Surgical, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704421965PackageGS11In Commercial Distribution
44026704421969PackageGS112In Commercial Distribution
04026704421961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670442196524026704421965
4402670442196944026704421969
04026704421961040267044219614026704421961

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA 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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length45Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00none

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594764692CARDINAL HEALTHCardinal Health 200, LLCMCA2022-08-12
50195594764690CARDINAL HEALTHCardinal Health 200, LLCMCA2022-08-12
34026704633174DEKNATELTELEFLEX INCORPORATEDMCA2019-09-05
34026704634003DEKNATELTELEFLEX INCORPORATEDMCA2019-09-04
14026704558947DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704558941DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704426363DEKNATELTELEFLEX INCORPORATEDMCA2017-12-12
34026704427445DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
34026704427452DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
04026704427161DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427444DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427451DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427165DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427448DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427455DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
34026704421962DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704426264DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704427254DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
24026704426151DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704426267DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427257DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427462DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421794DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421800DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421817DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704422005DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704558940DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421798DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421804DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421811DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16