Spreader Arm for Small Adult Sternum Retractor 1010900

GUDID 10817121000294

The device is intended to be used for sternal retraction on adult patients.

Coroneo Inc

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• Primary Device ID: 10817121000294
• NIH Device Record Key: 84dc3fd7-5017-47f0-9dc1-d4c970d3cc3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spreader Arm for Small Adult Sternum Retractor
• Version Model Number: 1010900
• Catalog Number: 1010900
• Company DUNS: 255276362
• Company Name: Coroneo Inc
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817121000294 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

[10817121000294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

Devices Manufactured by Coroneo Inc

• 00817121000532 - Spreader arm - Neonate sternum retractor: 2024-02-09 Crank-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
• 00817121000549 - Spreader arm - Neonate sternum retractor: 2024-02-09 Rack-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
• 00817121000556 - Spreader arm - Infant sternum retractor: 2024-02-09 Crank-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
• 00817121000563 - Spreader arm - Infant sternum retractor: 2024-02-09 Rack-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
• 00817121000570 - Pinion for pediatric retractors: 2024-02-09 Pinion for the pediatric retractors, within separable assemblies 1100210 (Infant Pediatric Retractor) and 1100211 (Neonate Pedia
• 10817121000584 - Pediatric sternum retractor, infant: 2024-02-09 Pediatric sternum retractor for the infant patient, comprises two spreader arms and one pinion.
• 10817121000591 - Pediatric sternum retractor, neonate: 2024-02-09 Sternum retractor for neonate patients. Comprises two spreader arms and a pinion.
• 10817121000492 - COR-VALV, Artial tissue retractor system: 2023-07-14 The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair of replacement of the mitral cardiac val