| Primary Device ID | 10817121000584 |
| NIH Device Record Key | 2823471b-ce84-470b-980c-e22d87c5aa6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric sternum retractor, infant |
| Version Model Number | 1100210 |
| Catalog Number | 1100210 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com | |
| Phone | 5143369230 |
| info@coroneo.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817121000584 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
[10817121000584]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
| 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 | 2024-02-09Pediatric sternum retractor for the infant patient, comprises two spreader arms and one pinion. |
| 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 |