PenBlade Safety Scalpel PB-M-11P

GUDID 20853624005012

The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

ZIEN MEDICAL TECHNOLOGIES, INC.

Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use

• Primary Device ID: 20853624005012
• NIH Device Record Key: adb4577c-a16b-42ab-b924-632e363925b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PenBlade Safety Scalpel
• Version Model Number: #11P Blade
• Catalog Number: PB-M-11P
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853624005018 [Unit of Use]
GS1	10853624005015 [Primary]
GS1	20853624005012 [Package]; Contains: 10853624005015; Package: Shipper [10 Units]; In Commercial Distribution
GS1	30853624005019 [Package]; Package: Overshipper [4 Units]; In Commercial Distribution

FDA Product Code

• GDX: Scalpel, One-Piece

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: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [PenBlade Safety Scalpel]

• 20853624005029: The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad
• 20853624005012: The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad
• 20853624005005: The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blad