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Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes

FDA UDI

Class I (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes FDA UDI
Generic Name
Sternum spreader FDA UDI
Device Name
Curved Sternal Latch Retractor with 2 sets of Blades and Atrial and Aortic Rakes: Suitable for adult patients weighing from 45 to 90 kg FDA UDI
Model / Reference
SRCL-AR FDA UDI
Description
Curved Sternal Latch Retractor with 2 sets of Blades and Atrial and Aortic Rakes: Suitable for adult patients weighing from 45 to 90 kg FDA UDI

Identifiers

Catalog Number
SRCL-AR FDA UDI
Primary DI / UDI-DI
B040SRCLAR0 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

Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID

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 7f269259-eb82-408e-98d6-e4f100a5be9e 35 fields · synced Jun 8, 2026