ORTHOMED

Primary DI
B8039602010
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 96-0201
Device description
CCR RADIOLUCENT 4-TEETH BLADE MEDIAL/LATERAL GREEN 19MM WIDE X 30MM DEEP
Published
2026-06-22
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
B8039602010PrimaryHIBCC0

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
B8034500040ORTHOMEDOM 45-00042026-07-14
B8034503260ORTHOMEDOM 45-03262026-07-14
B8034503660ORTHOMEDOM 45-03662026-07-14
B8034503700ORTHOMEDOM 45-03702026-07-14
B8034605720ORTHOMEDOM 46-05722026-07-14
B8034605730ORTHOMEDOM 46-05732026-07-14
B8034605740ORTHOMEDOM 46-05742026-07-14
B8034606180ORTHOMEDOM 46-06182026-07-14
B8034606190ORTHOMEDOM 46-06192026-07-14
B8034606210ORTHOMEDOM 46-06212026-07-14
B8034606250ORTHOMEDOM 46-06252026-07-14
B8034606370ORTHOMEDOM 46-063702026-07-14
B8034708900ORTHOMEDOM 47-08902026-07-14
B8034709150ORTHOMEDOM 47-09152026-07-14
B8034709160ORTHOMEDOM 47-09162026-07-14
B8034709170ORTHOMEDOM 47-09172026-07-14
B8034709180ORTHOMEDOM 47-09182026-07-14
B8034709190ORTHOMEDOM 47-09192026-07-14
B8034709290ORTHOMEDOM 47-09292026-07-14
B8034709510ORTHOMEDOM 47-09512026-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B803NL97020330ORTHOMEDORTHO-MED, INC.FGN2026-06-23
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