FDA.reportPublic FDA data

OCTOPi Suture Anchor System

Primary DI
09353903030331
Brand
OCTOPi Suture Anchor System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
OCBR24Ni
Catalog number
OCBR24Ni
Device description
OCTOBridge 2.4 with Needles
Published
2026-11-04
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903030331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903030331093539030303319353903030331

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
09353903030348OCTOPi Suture Anchor SystemOCAN242NiOCAN242Ni2026-11-04
09353903030379OCTOPi Suture Anchor SystemOCBR17NiOCBR17Ni2026-11-04
09353903030386OCTOPi Suture Anchor SystemOCAN172NiOCAN172Ni2026-11-04
09353903030393OCTOPi Suture Anchor SystemOCEX17iOCEX17i2026-11-04
09353903030416OCTOPi Suture Anchor SystemOCBR14NiOCBR14Ni2026-11-04
09353903030430OCTOPi Suture Anchor SystemOCAN142NiOCAN142Ni2026-11-04
09353903030461OCTOPi Suture Anchor SystemOCI24OCI242026-11-04
09353903030478OCTOPi Suture Anchor SystemOCI17OCI172026-11-04
09353903030485OCTOPi Suture Anchor SystemOCI14OCI142026-11-04
09353903004240FO NX Nail SystemKWDT-12150/1KWDT-12150/12026-10-12
09353903004257FO NX Nail SystemKWDT-16150/1KWDT-16150/12026-10-12
09353903002468FO Micro Screw SystemBTSC00023BTSC000232020-05-19
09353903002475FO Micro Screw SystemBTSC00024BTSC000242020-05-19
09353903002482FO Micro Screw SystemBTSC00025BTSC000252020-05-19
09353903002499FO Micro Screw SystemBTSC00026BTSC000262020-05-19
09353903002505FO Micro Screw SystemBTSC00027BTSC000272020-05-19
09353903002529FO Micro Screw SystemBTSC00029BTSC000292020-05-19
09353903002611FO Micro Screw SystemBTSC00038BTSC000382020-05-19
09353903002512FO Micro Screw SystemBTSC00028BTSC000282020-05-19
09353903008484FO Micro Screw SystemKWST-0706/1KWST-0706/12019-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
00889795154804Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154811Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154828Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDGAB2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03