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Device Explorer · FDA GUDID · GMDN 46771

Sternum spreader

A 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-adju

US‑registered devices212in commercial distribution
Companies13labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Teleflex Incorporated8641%
Ambler Surgical Corp.2210%
Steris Corporation2210%
Genesee Biomedical, Inc.199%
Integra Lifesciences Production Corporation188%
Schobell Industrial Ltda105%
Fehling Instruments Gmbh & Co. Kg94%
Coroneo Inc94%

Top labelers

CompanyDevicesShare
Teleflex Incorporated8641%
Ambler Surgical Corp.2210%
Steris Corporation2210%
Genesee Biomedical, Inc.199%
Integra Lifesciences Production Corporation188%
Schobell Industrial Ltda105%
Fehling Instruments Gmbh & Co. Kg94%
Coroneo Inc94%
Kdl Medical, Inc.63%
Kapp Surgical Instrument Co.63%
Maquet Cardiovascular Llc31%
Aesculap Ag10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAHEART XSDisposable Platform BladesFasTract Suture StaysFasTract Suture StayFasTract Modified Sternal Retractor, Deep BladesFasTract Sternal Retractor, Deep BladesFasTract Sternal RetractorHayden MedicalPinion for pediatric retractorsSpreader arm - Infant sternum retractorSpreader arm - Neonate sternum retractorCORONEO Sternum retractor, largeCORONEO Sternum retractor, smallACCESSRAIL Platform (Deep Blade)Ultima Activator II Drive Mechanism

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR79
GADRETRACTOR50
GADRetractor35
DWSInstruments, Surgical, Cardiovascular26
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY22
LRWScissors, General, Surgical1

GMDN & GCC registration

  • GMDN code 46771 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 96% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 47Length (Inch) · 45Length (Millimeter) · 33Width (Millimeter) · 31Length (Centimeter) · 4Width (Centimeter) · 2

Use these as the dimensions to specify in a tender line.

How many sternum spreader products are registered in the US?

212 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sternum spreader", from 13 companies. The largest labeler is Teleflex Incorporated with 41% of records.

Which FDA product codes apply?

DWS (INSTRUMENTS, SURGICAL, CARDIOVASCULAR), GAD (RETRACTOR), GAD (Retractor), DWS (Instruments, Surgical, Cardiovascular)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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