FDA.report

IMEDICOM HIGH SPEED BLADE

Primary DI
08800038024809
Brand
IMEDICOM HIGH SPEED BLADE
Company
IMEDICOM CO., LTD.
Model
NSR-711D
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HTTBurr, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800038024809PackageGS110In Commercial Distribution
08809288932520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800038024809088000380248098800038024809
08809288932520088092889325208809288932520

GMDN Terms

TermDefinition
Orthopaedic osteotome blade, single-useA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on both sides; it is made of high-grade stainless steel. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690340653
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08800038060340EZImpactorBMA-P20-S012026-01-22
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08800038029361SteriSpine VA KITKYPHO15B2025-09-24
08800038029378SteriSpine VA KITKYPHO20B2025-09-24
08800038029415SteriSpine VA SPICD-CA2/ SPICD-NDB22025-09-24
08800038029422SteriSpine VA SPICD-CA2/ SPICD-NDT22025-09-24
08800038039407SteriSpine VA SPICD-CA1/ SPICD-NDB12025-09-24
08800038039414SteriSpine VA SPICD-CA1/ SPICD-NDD12025-09-24
08800038039421SteriSpine VA SPICD-CA1/ SPICD-NDT12025-09-24
08800038039438SteriSpine VA SPICD-CA2/ SPICD-NDD22025-09-24
08800038039445SteriSpine VA SPICD-SP12025-09-24
08800038039452SteriSpine VA SPICD-BI1/ SPICD-BIC12025-09-24
08800038039469SteriSpine VA SPICD-CP1/ SPICD-CF12025-09-24
08800038039476SteriSpine VA SPICD-CP1/ SPICD-CFS12025-09-24

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