FDA.reportPublic FDA data

ORTHOMED

Primary DI
B803907925010
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 90-7925-01
Device description
INFER-POSTERIOR ACETABULAR CAPSULE RETRACTOR MED RIGHT
Published
2026-01-22
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
B803907925010PrimaryHIBCC0

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
B8035202620ORTHOMEDOM 52-02622026-04-16
B8035202640ORTHOMEDOM 52-02642026-04-16
B8035202660ORTHOMEDOM 52-02662026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159040272SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040289SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040296SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040302SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040319SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040326SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040333SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040340SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040357SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040364SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040371SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
B7687425470Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
B7687425570Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
00810055254897Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055254903Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258871Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258888Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258895Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258901Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258918Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258925Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258932Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258956Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258963Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258970Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258987Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258994Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259007Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259014Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259021Surgical DesignSurgical Design, Inc.GAD2026-06-01