FDA.reportPublic FDA data

OCTOPi Suture Anchor System

Primary DI
09353903030225
Brand
OCTOPi Suture Anchor System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
OCBR24ND
Catalog number
OCBR24ND
Device description
OCTOBridge Push 2.4 with Needles and Cannulated Drill
Published
2026-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable
HTWBit, Drill
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030225093539030302259353903030225

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from moisture and direct heat.

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903001805FO Micro Screw SystemBTSC00077BTSC000772020-05-19
09353903001812FO Micro Screw SystemBTSC00078BTSC000782020-05-19
09353903001829FO Micro Screw SystemBTSC00079BTSC000792020-05-19
09353903001836FO Micro Screw SystemBTSC00080BTSC000802020-05-19
09353903001843FO Micro Screw SystemBTSC00081BTSC000812020-05-19
09353903001850FO Micro Screw SystemBTSC00082BTSC000822020-05-19
09353903001867FO Micro Screw SystemBTSC00083BTSC000832020-05-19
09353903001874FO Micro Screw SystemBTSC00084BTSC000842020-05-19
09353903001881FO Micro Screw SystemBTSC00085BTSC000852020-05-19
09353903001898FO Micro Screw SystemBTSC00086BTSC000862020-05-19
09353903001904FO Micro Screw SystemBTSC00087BTSC000872020-05-19
09353903001911FO Micro Screw SystemBTSC00088BTSC000882020-05-19
09353903002079FO Micro Screw SystemBTSC00006BTSC000062020-05-19
09353903002086FO Micro Screw SystemBTSC00007BTSC000072020-05-19
09353903002093FO Micro Screw SystemBTSC00008BTSC000082020-05-19
09353903002109FO Micro Screw SystemBTSC00009BTSC000092020-05-19
09353903002116FO Micro Screw SystemBTSC00010BTSC000102020-05-19
09353903002123FO Micro Screw SystemBTSC00011BTSC000112020-05-19
09353903002130FO Micro Screw SystemBTSC00012BTSC000122020-05-19
09353903002147FO Micro Screw SystemBTSC00013BTSC000132020-05-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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