ORTHOMED

Primary DI
B8034708750
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 47-0875
Device description
"FERRIS SMITH IVD RONG.7"" DWN 6X12MM"
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRYPunch, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8034708750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
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
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10304040193300Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193317Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193324Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
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10304040193348Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
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10304040177904Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177843Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
10304040177898Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
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B8034800320ORTHOMEDORTHO-MED, INC.LRY2024-02-13
B8034800330ORTHOMEDORTHO-MED, INC.LRY2024-02-13
B8034708660ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708680ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708700ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708720ORTHOMEDORTHO-MED, INC.LRY2023-09-12
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B8034708740ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708780ORTHOMEDORTHO-MED, INC.LRY2023-09-12
B8034708790ORTHOMEDORTHO-MED, INC.LRY2023-09-12
10885632351198HalyardOWENS & MINOR DISTRIBUTION, INC.LRY2022-03-23