COOLEY DERRA CLAMP

GUDID B09921003490

COOLEY DERRA CLAMP CURVED LARGE

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable
Primary Device IDB09921003490
NIH Device Record Keyd4ea4e06-e84a-4fdc-b2c3-14f0b166f43d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOOLEY DERRA CLAMP
Version Model Number2100-349
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 Batchfalse
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

Length6.75 Inch
Length6.75 Inch
Length6.75 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896002166 [Primary]
HIBCCB09921003490 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09921003490]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921003490]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921003490]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2018-08-23

On-Brand Devices [COOLEY DERRA CLAMP ]

B09921003550COOLEY DERRA CLAMP SMALL JAW
B09921003450COOLEY DERRA CLAMP CURVED SMALL
B09921003490COOLEY DERRA CLAMP CURVED LARGE
B09921003470COOLEY DERRA CLAMP CURVED MEDIUM
B09921003600COOLEY DERRA CLAMP ATRAUMATIC LARGE JAW
00192896101708COOLEY DERRA CLAMP CURVED TIP LARGE SIZE

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