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Child Curved Sternal Retractor with Blades Only

FDA UDI

Class I (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Child Curved Sternal Retractor with Blades Only FDA UDI
Generic Name
Sternum spreader FDA UDI
Device Name
Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg FDA UDI
Model / Reference
CSR-AR FDA UDI
Description
Child Curved Sternal Latch Retractor with atrial and aortic rakes: Suitable for patients weighing from 15 to 45 kg FDA UDI

Identifiers

Catalog Number
CSR-AR FDA UDI
Primary DI / UDI-DI
B040CSRAR0 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Sternum spreader FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Sternum spreader

Child Curved Sternal Retractor with Blades Only by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sternum spreader.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesee Biomedical, Inc.

Sources (1)

  • FDA UDI 6e3be4bf-57e4-4f7b-9e61-02c7502f1e5c 35 fields · synced Jun 8, 2026