Alpin

GUDID 20841019109476

Bipolar Pencil 18 Gauge Straight

Alpin Surgical Specialties Inc

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 20841019109476
• NIH Device Record Key: 47f21a30-08ea-4493-b9e1-5998c75a7f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpin
• Version Model Number: A145000
• Company DUNS: 131199135
• Company Name: Alpin Surgical Specialties 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019109472 [Primary]
GS1	10841019109479 [Package]; Contains: 00841019109472; Package: [10 Units]; In Commercial Distribution
GS1	20841019109476 [Package]; Contains: 00841019109472; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864402

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[20841019109476]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-19

On-Brand Devices [Alpin]

• 20841019109483: Bipolar Pencil 18 Gauge Curved
• 20841019109476: Bipolar Pencil 18 Gauge Straight
• 20841019109469: Bipolar Jewelers/Iris Forceps, 0.4mm Tip
• 20841019109452: Disposable Bipolar Cord 12ft. (366cm)