Walcott Rx

GUDID 00841019109762

Reusable Irrigation or Aspiration Handpiece (for use with disposable cannulas)

Walcott Rx Product Inc

Surgical irrigation/aspiration handpiece, reusable

• Primary Device ID: 00841019109762
• NIH Device Record Key: 7bbe9a7b-d63c-48bc-a50a-76b8bcd53fbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walcott Rx
• Version Model Number: RX13-5030
• Company DUNS: 837689694
• Company Name: Walcott Rx Product Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com
• Phone: 781-834-9500
• Email: kprario@ksp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019109762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930113

FDA Product Code

• HMX: Cannula, Ophthalmic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

[00841019109762]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-07-04

On-Brand Devices [Walcott Rx]

• 00841019109762: Reusable Irrigation or Aspiration Handpiece (for use with disposable cannulas)
• 10841019110017: Tungsten Microdissection Needle 2" (5.1cm), Insulated, Straight
• 10841019110000: Tungsten Microdissection Needle 1 5/8" (4.1cm), Insulated, Straight
• 10841019109998: Tungsten Microdissection Needle 1 1/4" (3.2cm), Insulated, Straight
• 20841019109988: Disposable 10 ft. (300cm) Monopolar Endoscopic Cord
• 00841019109977: Reusable Bipolar Pencil 20/23 Gauge, Tapered Tip, Blunt
• 00841019109960: Reusable Bipolar Pencil 20/23 Gauge, Tapered Tip, Sharp
• 00841019109953: Reusable Bipolar Pencil 20 Gauge, Straight
• 00841019109946: Reusable Bipolar Pencil 18 Gauge, Curved
• 00841019109939: Reusable Bipolar Pencil 18 Gauge, Straight
• 20841019109926: Bipolar Pencil 25 Gauge Straight
• 20841019109919: Bipolar Pencil 20/23 Gauge Tapered Tip, Blunt
• 20841019109902: Bipolar Pencil 23 Gauge
• 20841019109896: Bipolar Pencil 20/23 Gauge Tapered Tip, Sharp
• 20841019109889: Bipolar Pencil 20 Gauge
• 20841019109872: Bipolar Pencil 18 Gauge Curved
• 20841019109865: Bipolar Pencil 18 Gauge Straight
• 20841019109858: Bipolar Jewelers/Iris Forceps, 0.4mm Tip
• 00841019109847: Reusable Bipolar Forceps 3 1/2" (8.9cm) Iris, Curved, 0.4mm Tips
• 00841019109830: Reusable Bipolar Forceps 3 1/2" (8.9cm) Iris, Straight, 0.4mm Tips
• 00841019109823: Reusable Bipolar Silicone Cord (with O.M.S. - Type Plug)
• 00841019109816: 12 ft. Reusable Bipolar Silicone Cord with Fischer Plug
• 00841019109809: 12 ft. Reusable Bipolar Silicone Cord
• 00841019109793: Reusable Bipolar Thermoplastic Rubber Cord
• 20841019109780: Disposable Bipolar Cord 12 ft.(360cm)
• 00841019109779: Reusable Bipolar Forceps 4" (10.2cm) Jewelers, Straight 0.4mm Tips