FDA.report

LEOPARD

Primary DI
08809317170671
Brand
LEOPARD
Company
IMEDICOM CO., LTD.
Model
ISA-100R
Device description
Reamer Attachment
Published
2023-07-10
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

Related Records

Product Codes

CodeName
GETMotor, Surgical Instrument, Pneumatic Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809317170671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809317170671088093171706718809317170671

GMDN Terms

TermDefinition
Bone/joint surgical power tool motorized handpiece/set, pneumaticA pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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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08809317170701LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170817LEOPARDIMEDICOM CO., LTD.GET2023-07-10
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