FDA.reportPublic FDA data

CLEAR FLUSH

Primary DI
B508CC101MM90
Brand
CLEAR FLUSH
Company
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
Model
CC10-1MM90
Device description
"CERMIC COAT KERRISON RONGEUR 10"" 1MM 90 DEGREE"
Published
2017-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B508CC101MM90PrimaryHIBCC0

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
080478537
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B508A11020AIM CLEAR FLUSHA1-10202017-03-13
B508A11363AIM CLEAR FLUSHA1-13632017-03-13
B508A21007AIM CLEAR FLUSHA2-10072017-03-13
B508A21012AIM CLEAR FLUSHA2-10122017-03-13
B508A4316AIM LAPAim4-3162017-10-16
B508A4317AIM LAPA4-3172017-03-13
B508A4318AIM LAPA4-3182017-03-13
B508A4319AIM LAPA4-3192017-03-13
B508A4L317AIM LAPA4-317L2017-03-13
B508A4L318AIM LAPA4-318L2017-03-13
B508A4L319AIM LAPA4-319L2017-03-13
B508A5300AIM LAPA5-3002017-03-13
B508A5315AIM LAPA5-3152017-03-13
B508EA11080Aim Clear FlushA1-10802017-06-12
B508EA11360AIMA1-13602017-06-12
B508EA11363AIM A1-13632017-05-30
B508EA21012AIM CLEAR FLUSHA2-10122017-10-16
B508ESLA11225AIM CLEAR FLUSHA1-1225SL2017-05-02
B508ESLA11226AIM CLEAR FLUSHA1-1226SL2017-05-02
B508ESLA11230AIM CLEAR FLUSHA1-1230SL2017-05-02

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Primary DI, Brand, Company table
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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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