FDA.reportPublic FDA data

DEKNATEL

Primary DI
24026704421811
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN010207
Catalog number
8-5062W
Device description
CTY WH TP 3MM AC-25 2N 18
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

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
24026704421811PackageGS11In Commercial Distribution
44026704421815PackageGS112In Commercial Distribution
04026704421817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670442181124026704421811
4402670442181544026704421815
04026704421817040267044218174026704421817

GMDN Terms#

Term, Definition table
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#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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
04026704421961DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704422005DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704558940DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421798DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421804DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16