03392

GUDID ESOT033921

14 C 33 8-0, Taper Lux 8-0, Nylon black, 15cm, sterile Box with 12 sutures

S & T AG

Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament
Primary Device IDESOT033921
NIH Device Record Key56c23bde-b2fc-41ba-b9cf-3ae36f38a40a
Commercial Distribution Discontinuation2020-03-10
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberSurgical suture nonabsorbable monofil Taper Lux
Catalog Number03392
Company DUNS481542926
Company NameS & T AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net
Phone+41526727407
Emailinfo@s-and-t.net

Device Dimensions

Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0
Length15 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-sterilise
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCESOT033920 [Primary]
HIBCCESOT033921 [Package]
Contains: ESOT033920
Package: [12 Units]
Discontinued: 2020-03-10
Not in Commercial Distribution

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-12
Device Publish Date2016-09-24

Devices Manufactured by S & T AG

ESOT010751 - NA2023-03-09 ICL-1323-0.A Instrument Case 13 x 23 cm for 8 instruments
ESOT011851 - NA2023-03-09 ICH-1323-0.A Instrument Case 230 x 130 x 50 mm, without rack
ESOT031470 - NA2020-03-12 10 V 34 10-0, Taper Point, 10-0, Nylon black, 15 cm, sterile, Box with 12 sutures
ESOT031481 - NA2020-03-12 10 V 34 9-0, Taper Point 9-0, Nylon black, 15 cm, sterile Box with 12 sutures
ESOT031671 - NA2020-03-12 5 V 33 11-0, Taper Point 11-0, Nylon black, 10 cm, sterile Box with 12 sutures
ESOT031701 - NA2020-03-12 7 V 33 11-0, Taper Point 11-0, Nylon black, 10 cm, sterile Box with 12 sutures
ESOT031711 - NA2020-03-12 7 V 33 10-0, Taper Point 10-0, Nylon black, 10 cm, sterile Box with 12 sutures
ESOT031741 - NA2020-03-12 7 V 43 10-0, Taper Point 10-0, Nylon black, 10 cm, sterile Box with 12 sutures

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.