Rosenkranz Pediatric Open Heart Retractor K-216

GUDID B033K216

Child Malleable Blade

Kapp Surgical Instrument Co.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: B033K216
• NIH Device Record Key: c4a92355-6f6e-480e-83e8-b63c6ad0731c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rosenkranz Pediatric Open Heart Retractor
• Version Model Number: K-216
• Catalog Number: K-216
• Company DUNS: 004171112
• Company Name: Kapp Surgical Instrument Co.
• Device Count: 1
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B033K216 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[B033K216]

Moist Heat or Steam Sterilization

[B033K216]

Moist Heat or Steam Sterilization

[B033K216]

Moist Heat or Steam Sterilization

[B033K216]

Moist Heat or Steam Sterilization

[B033K216]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [Rosenkranz Pediatric Open Heart Retractor]

• B033K217: Pediatric malleable blade.
• B033K216: Child Malleable Blade