ORTHOMED

Primary DI
B803COD5045710
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM COD 50-4571
Device description
KELLY BLADE 2" X 6"
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FGNRetractor, Non-Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B803COD5045710PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
B8035202680ORTHOMEDOM 52-02682026-06-26
B803PS0099100A0ORTHOMEDOM PS00.991-00A2026-06-26
B803PS00991080ORTHOMEDOM PS00 991-082026-06-26
B803PS0099108A0ORTHOMEDOM PS00 991-08A2026-06-26
B803PS00991090ORTHOMEDOM PS00 991-092026-06-26
B803PS0099109A0ORTHOMEDOM PS00 991-09A2026-06-26
B803PS00991100ORTHOMEDOM PS00 991-102026-06-26
B803PS0099110A0ORTHOMEDOM PS00 991-10A2026-06-26
B803PS0395900ORTHOMEDOM PS03.959-02026-06-26
B803PS03959000ORTHOMEDOM PS03.959-002026-06-26
B803PS039590000ORTHOMEDOM PS03.959-0002026-06-26
B803PS0395910ORTHOMEDOM PS03.959-12026-06-26
B803PS0395920ORTHOMEDOM PS03.959-22026-06-26
B803PS0395930ORTHOMEDOM PS03.959-32026-06-26
B803PS0395950ORTHOMEDOM PS03.959-52026-06-26
B803PS0395960ORTHOMEDOM PS03.959-62026-06-26
B803PS0595940ORTHOMEDOM PS03.959-42026-06-26
B803NL97020450ORTHOMEDOM NL9702-0452026-06-25
B803PS00991010ORTHOMEDOM PS00 991-012026-06-25
B803PS0099101A0ORTHOMEDOM PS00 991-01A2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B803NL97020450ORTHOMEDORTHO-MED, INC.FGN2026-06-25
B803COD5045680ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803COD5045690ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803COD5045700ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107210ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107230ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107370ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107390ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108340ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108360ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108370ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020100ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020110ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020120ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020130ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020140ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020150ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020200ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020210ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020220ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020230ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020240ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020250ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020260ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020300ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020310ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020320ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020330ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020340ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020360ORTHOMEDORTHO-MED, INC.FGN2026-06-23