Bausch & Lomb

GUDID 20757770457278

Bipolar Pencil, 18 Gauge Disposable Straight

Bausch & Lomb Incorporated

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID20757770457278
NIH Device Record Key7174af6a-81c2-4a01-ac60-2b1c52c41cbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBausch & Lomb
Version Model NumberE7918
Company DUNS002207751
Company NameBausch & Lomb Incorporated
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

Phone781-834-9500
Emailkprario@ksp.com
Phone781-834-9500
Emailkprario@ksp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100757770457274 [Primary]
GS120757770457278 [Package]
Contains: 00757770457274
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20757770457278]

Radiation Sterilization


[20757770457278]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-31

On-Brand Devices [Bausch & Lomb]

20757770457292Disposable Bipolar Pencil, 23 Gauge, Tapered Tip
20757770457285Disposable Bipolar Pencil, 18 Gauge, Curved
20757770457278Bipolar Pencil, 18 Gauge Disposable Straight
00310119043288Soft Contact Lens Disinfecting Solution, 2oz (60ml)

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