Walcott Rx

GUDID 20841019109889

Bipolar Pencil 20 Gauge

Walcott Rx Product Inc

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID20841019109889
NIH Device Record Key2069fb79-829b-4b08-87c1-f3d11121c770
Commercial Distribution StatusIn Commercial Distribution
Brand NameWalcott Rx
Version Model NumberRX14-5004
Company DUNS837689694
Company NameWalcott Rx Product 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841019109885 [Primary]
GS110841019109882 [Package]
Contains: 00841019109885
Package: [10 Units]
In Commercial Distribution
GS120841019109889 [Package]
Contains: 00841019109885
Package: [50 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

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

[20841019109889]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-04

On-Brand Devices [Walcott Rx]

00841019109762Reusable Irrigation or Aspiration Handpiece (for use with disposable cannulas)
10841019110017Tungsten Microdissection Needle 2" (5.1cm), Insulated, Straight
10841019110000Tungsten Microdissection Needle 1 5/8" (4.1cm), Insulated, Straight
10841019109998Tungsten Microdissection Needle 1 1/4" (3.2cm), Insulated, Straight
20841019109988Disposable 10 ft. (300cm) Monopolar Endoscopic Cord
00841019109977Reusable Bipolar Pencil 20/23 Gauge, Tapered Tip, Blunt
00841019109960Reusable Bipolar Pencil 20/23 Gauge, Tapered Tip, Sharp
00841019109953Reusable Bipolar Pencil 20 Gauge, Straight
00841019109946Reusable Bipolar Pencil 18 Gauge, Curved
00841019109939Reusable Bipolar Pencil 18 Gauge, Straight
20841019109926Bipolar Pencil 25 Gauge Straight
20841019109919Bipolar Pencil 20/23 Gauge Tapered Tip, Blunt
20841019109902Bipolar Pencil 23 Gauge
20841019109896Bipolar Pencil 20/23 Gauge Tapered Tip, Sharp
20841019109889Bipolar Pencil 20 Gauge
20841019109872Bipolar Pencil 18 Gauge Curved
20841019109865Bipolar Pencil 18 Gauge Straight
20841019109858Bipolar Jewelers/Iris Forceps, 0.4mm Tip
00841019109847Reusable Bipolar Forceps 3 1/2" (8.9cm) Iris, Curved, 0.4mm Tips
00841019109830Reusable Bipolar Forceps 3 1/2" (8.9cm) Iris, Straight, 0.4mm Tips
00841019109823Reusable Bipolar Silicone Cord (with O.M.S. - Type Plug)
0084101910981612 ft. Reusable Bipolar Silicone Cord with Fischer Plug
0084101910980912 ft. Reusable Bipolar Silicone Cord
00841019109793Reusable Bipolar Thermoplastic Rubber Cord
20841019109780Disposable Bipolar Cord 12 ft.(360cm)
00841019109779Reusable Bipolar Forceps 4" (10.2cm) Jewelers, Straight 0.4mm Tips
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