Dynamic DIAGNOSTICS, INC

GUDID 20851255007115

Slim, Rocker, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package

BIOPROTECH INC.

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

• Primary Device ID: 20851255007115
• NIH Device Record Key: 367bab44-74eb-4e0f-8714-b7931f844998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamic DIAGNOSTICS, INC
• Version Model Number: PEN41
• Company DUNS: 688460539
• Company Name: BIOPROTECH 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851255007111 [Primary]
GS1	10851255007118 [Package]; Package: Carton Box [4 Units]; In Commercial Distribution
GS1	20851255007115 [Package]; Contains: 00851255007111; Package: Inner Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092732

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-20
• Device Publish Date: 2025-03-12

On-Brand Devices [Dynamic DIAGNOSTICS, INC]

• 00851255007586: 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister, No Blade, Non-sterile, 200 pcs per bulk pack
• 10851255007163: Horizontal, Corded, Adult or Pediatric, Solid, 150x120mm, Foam, RF connector
• 10851255007156: Horizontal, Non-corded, Adult or Pediatric, Split, 150x120mm, Foam, 5pcs per pouch
• 10851255007149: Horizontal, Non-corded, Adult or Pediatric, Solid, 150x120mm, Foam, 5pcs per pouch
• 10851255007132: Horizontal, Corded, Adult or Pediatric, Split, 150x120mm, Foam
• 10851255007125: Horizontal, Corded, Adult or Pediatric, Solid, 150x120mm, Foam
• 20851255007115: Slim, Rocker, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holste
• 20851255007108: Slim, Button, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holste
• 20851255007092: Slim, Rocker, 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister packa
• 00851255007081: 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Non-sterile, 200 pcs
• 00851255007074: 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, non-sterile
• 00851255007067: 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Non-sterile, 200 pcs per bu
• 00851255007050: 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister, Non-sterile, 200 p
• 20851255007047: Slim, Button, 2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister packa