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Pediatric Curved Sternal Retractor

FDA UDI

Class I (US FDA UDI)

by Genesee Biomedical, Inc.

Identity

Trade Name
Pediatric Curved Sternal Retractor FDA UDI
Generic Name
Sternum spreader FDA UDI
Device Name
Pediatric Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 2 to 15kg FDA UDI
Model / Reference
PSRC-1 FDA UDI
Description
Pediatric Curved Sternal Latch Retractor with 2 sets of Blades: Suitable for patients weighing from 2 to 15kg FDA UDI

Identifiers

Catalog Number
PSRC-1 FDA UDI
Primary DI / UDI-DI
B040PSRC1 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

Pediatric Curved Sternal Retractor 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 ab624400-bbcf-45c7-b943-01419fc4194f 35 fields · synced May 30, 2026