FDA.report

DEKNATEL

Primary DI
34026704423980
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN025269
Catalog number
RC-1050
Device description
RC TIE PAK SLK X2
Published
2017-03-24
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
34026704423980PackageGS16In Commercial Distribution
04026704423989PreviousGS10
14026704423986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670442398034026704423980
04026704423989040267044239894026704423989
1402670442398614026704423986

GMDN Terms

TermDefinition
Silk suture, sterileA sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length45Centimeter

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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160515157MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-03-05
50198956254730CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
50198956369359CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956410815CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956377477CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
50198956318388CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
20809160509750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-01-21
50198956325133CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
50198956201840CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956299977CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956285710CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
50198956249866CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956250053CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956192964CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
50198956199628CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956279795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956241846CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
50198956284560CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956284676CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956233520CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
50198956185126CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
50198956192889CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
20809160494896Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-19
50198956132311CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04
20809160493585Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-04
20809160493257Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-02
50198956170795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-19
50198956160345CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-05
50198956150131CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-28
50198956132083CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-11