FDA.report

CLEAR FLUSH

Primary DI
B508PINSS103MM40
Brand
CLEAR FLUSH
Company
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
Model
SS10-3MM40PIN
Device description
STAINLESS STEEL KERRISON RONGEUR 10" 3MM BITE 40 DEGREE PIN EJECTOR
Published
2017-01-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HAERongeur, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B508PINSS103MM40PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080478537
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
B508A11363AIM CLEAR FLUSHA1-13632017-03-13
B508A21007AIM CLEAR FLUSHA2-10072017-03-13
B508A21012AIM CLEAR FLUSHA2-10122017-03-13
B508CC101MM90CLEAR FLUSHCC10-1MM902017-01-24
B508CC103MM40CLEAR FLUSHCC10-3MM402017-02-20
B508EA11020AIM CLEAR FLUSHA1-10202017-05-02
B508ECC101MM40AIM CLEAR FLUSHCC101MM402017-05-30
B508EPINCC103MM40AIM CLEAR FLUSHCC10-3MM40PIN2017-05-30
B508ESLA11226AIM CLEAR FLUSHA1-1226SL2017-05-02
B508ESLA11230AIM CLEAR FLUSHA1-1230SL2017-05-02
B508PINCC102MM40CLEAR FLUSHCC10-2MM40PIN2017-02-20
B508PINCC113MM40CLEAR FLUSHCC11-3MM40PIN2017-02-20
B508PINCC72MM40CLEAR FLUSHCC7-2MM40PIN2017-02-20
B508PINCC73MM40CLEAR FLUSHCC7-3MM40PIN2017-02-20
B508PINCC84MM40CLEAR FLUSHCC8-4MM40PIN2017-02-20
B508PINSC93MM40CLEAR FLUSHSC9-3MM40PIN2017-03-24
B508PINSC94MM40CLEAR FLUSHSC9-4MM40PIN2017-03-24
B508PINSS105MM40CLEAR FLUSHSS10-5MM40PIN2017-01-23
B508PINSS114MM40CLEAR FLUSHSS11-4MM40PIN2017-01-23
B508PINSS74MM40CLEAR FLUSHSS74MM40PIN2017-01-23

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