STRETCH PIN

GUDID B0991530116070

STRECH PIN FOR FLEXIBLE TROCAR SLEEVE

SONTEC INSTRUMENTS, INC.

Laparoscopic multi-instrument access port, reusable Laparoscopic multi-instrument access port, reusable Laparoscopic multi-instrument access port, reusable
Primary Device IDB0991530116070
NIH Device Record Key9c11bfa5-8d2f-447e-9f05-d4fb787adb13
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRETCH PIN
Version Model Number15-30116-07
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM

Device Dimensions

Width7 Millimeter
Width7 Millimeter
Width7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896000223 [Primary]
HIBCCB0991530116070 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0991530116070]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0991530116070]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0991530116070]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-20
Device Publish Date2018-08-20

On-Brand Devices [STRETCH PIN]

B0991530116080STRECH PIN FOR FLEXIBLE TROCAR SLEEVE
B0991530116070STRECH PIN FOR FLEXIBLE TROCAR SLEEVE
B0991530116060STRETCH PIN FOR FLEXIBLE TROCAR SLEEVE

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