FDA.reportPublic FDA data

Premature Hinged Sternal Retractor

Primary DI
B040PHR10
Brand
Premature Hinged Sternal Retractor
Company
GENESEE BIOMEDICAL, INC.
Model
PHR-1
Device description
Premature Hinged Sternal Retractor
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040PHR10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sternum spreaderA self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-786-4880cservice@geneseebiomedical.com

Regulatory Flags#

DUNS number
939872651
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B040MIRSTS0Sterilization TrayMIR-STS2026-09-29
B040RPS181100Thoracic Port with Obturator 18x110mmRPS-181102026-03-25
B040RPS18500Thoracic Port with Obturator 18x50mmRPS-18502026-03-25
B040RPS18700Thoracic Port with Obturator 18x70mmRPS-18702026-03-25
B040RPS18900Thoracic Port with Obturator 18x90mmRPS-18902026-03-25
B040TF260TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF280TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF300TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF320TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF340TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF380TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF400TransForm McCarthy Annuloplasty RingTF-402024-12-23
B040TF240TransForm McCarthy Annuloplasty RingTF-242024-12-23
B040TF26TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF28TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF30TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF32TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF34TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF360TransForm McCarthy Annuloplasty RingTF-362024-12-23
B040TF38TransForm McCarthy Annuloplasty RingTF-382024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436254MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436315MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436353MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436377MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436438MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776434410MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434489MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434298MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776434359MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776433307MillenniumAvalign Technologies, Inc.DWS2026-10-05
03661219323785DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323815DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323822DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323839DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
00190776432843MillenniumAvalign Technologies, Inc.DWS2026-09-29
B040MIRSTS0Sterilization TrayGENESEE BIOMEDICAL, INC.DWS2026-09-29
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04