FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8035202620
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 52-0262
Device description
"VOLKMAN RETR.8 1/2"" 3 PR SH RNG HDL"
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8035202620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B803904210SS0ORTHOMEDOM 90-4210-SSOM 90-4210-SS2026-05-08
B8037105136R0ORTHOMEDOM 71-0513-6ROM 71-0513-6R2026-05-01
B803KWIRE10C150S0ORTHOMEDKWIRE-10C-150SKWIRE-10C-150S2026-05-01
B8034802690ORTHOMEDOM 18-02692026-04-16
B8034803200ORTHOMEDOM 48-03202026-04-16
B8034803220ORTHOMEDOM 48-03222026-04-16
B8034803240ORTHOMEDOM 48-03242026-04-16
B8034803700ORTHOMEDOM 48-03702026-04-16
B8034803720ORTHOMEDOM 48-03722026-04-16
B8034803860ORTHOMEDOM 48-03862026-04-16
B8034803880ORTHOMEDOM 48-03882026-04-16
B8035202080ORTHOMEDOM 52-02082026-04-16
B8035202120ORTHOMEDOM 52-02122026-04-16
B8035202140ORTHOMEDOM 52-02142026-04-16
B8035202160ORTHOMEDOM 52-02162026-04-16
B8035202540ORTHOMEDOM 52-02542026-04-16
B8035202580ORTHOMEDOM 52-02582026-04-16
B8035202640ORTHOMEDOM 52-02642026-04-16
B8035202660ORTHOMEDOM 52-02662026-04-16
B8034709310ORTHOMEDOM 47-0931OM 47-09312026-03-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
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08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
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08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10
08800071700395Tiger View Kims Med Co.,Ltd.GAD2025-02-10
G141549052210Carnegie Surgical LLCCarnegie Surgical LLCGAD2025-01-17
08403207002334Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207002440Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207131218Anmuth Medical InternationalAnmuth Medical International, LLCGAD2023-11-16
G4533352400010PEAK MEDICALPeak Medical Distribution Inc.GAD2023-05-24
G141554311025S0Carnegie Surgical LLCCarnegie Surgical LLCGAD2023-02-13