BIOPSY CUP INSERT

GUDID B0992901127S0

BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device IDB0992901127S0
NIH Device Record Keyf9760ea3-a572-442f-bfcb-71a02eac5132
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOPSY CUP INSERT
Version Model Number2901-127S
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

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length330 Millimeter
Length330 Millimeter
Length330 Millimeter
Length330 Millimeter
Length330 Millimeter
Length330 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896007451 [Primary]
HIBCCB0992901127S0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-08
Device Publish Date2018-08-22

On-Brand Devices [BIOPSY CUP INSERT]

B0992901127S0BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT
B09929011110BIOPSY CUP WITHOUT THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
B0992901129S0BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
B0992901129L0BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
B09929011290BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
B0992901127L0BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT
B09929011270BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SAHFT
B0992901125S0BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
B0992901125L0BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
B09929011250BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
B0992901123S0BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT
B0992901123L0BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT
B09929011230BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT
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