Holster Option HO-28

GUDID M397HO280

Holster (Accessory) use for the Handpiece Holder

PLASMA SURGICAL, INC

Plasma surgical system handpiece

• Primary Device ID: M397HO280
• NIH Device Record Key: 15c79876-5b2b-413f-9e02-8dceac0f5fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holster Option
• Version Model Number: HO-28
• Catalog Number: HO-28
• Company DUNS: 360799048
• Company Name: PLASMA SURGICAL, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com
• Phone: 6785784390
• Email: cs@plasmasurgical.com

Device Dimensions

• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter
• Length: 28 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M397HO280 [Primary]
HIBCC	M397HO282 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121977

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-08
• Device Publish Date: 2018-10-01

Devices Manufactured by PLASMA SURGICAL, INC

• M397S2CDU122 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
• M397S2CDU12H0 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
• M397S2CDU282 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System
• M397S2CDU28H2 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System
• M397S2CDU72 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
• M397S2CDU7H0 - PlasmaJet Neutral Plasma Surgery System: 2023-09-15 Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
• M397OSCP0512H2 - PlasmaJet Neutral Plasma Surgery System: 2021-06-08 Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
• M397GCDU070 - PlasmaJet Neutral Plasma Surgery System: 2021-06-08 Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System