FDA.reportPublic FDA data

Flower Orthopedics

Primary DI
00840118125079
Brand
Flower Orthopedics
Company
FLOWER ORTHOPEDICS CORPORATION
Model
FIS 225
Device description
Flower Drill S, D:1.5mm, sterile, single use
Published
2024-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118125079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118125079008401181250798401181250790840118125079

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)778-8587info@flowerortho.com

Regulatory Flags#

DUNS number
078790947
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118126199Active CompressionOTP0552025-12-01
00840118126298Active CompressionSHADP2025-12-01
00840118126526Active CompressionOC701202025-12-01
00840118116800ZERO Profile Interlocking Cortex Screw, 3.5mm x 10mm, T15, Flex-Thread™8525-10-S2021-03-19
00840118116817ZERO Profile Interlocking Cortex Screw, 3.5mm x 12mm, T15, Flex-Thread™8525-12-S2021-03-19
00840118116824ZERO Profile Interlocking Cortex Screw, 3.5mm x 14mm, T15, Flex-Thread™8525-14-S2021-03-19
00840118116831ZERO Profile Interlocking Cortex Screw, 3.5mm x 16mm, T15, Flex-Thread™8525-16-S2021-03-19
00840118116848ZERO Profile Interlocking Cortex Screw, 3.5mm x 18mm, T15, Flex-Thread™8525-18-S2021-03-19
00840118116855ZERO Profile Interlocking Cortex Screw, 3.5mm x 20mm, T15, Flex-Thread™8525-20-S2021-03-19
00840118116862ZERO Profile Interlocking Cortex Screw, 3.5mm x 22mm, T15, Flex-Thread™8525-22-S2021-03-19
00840118116879ZERO Profile Interlocking Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™8525-24-S2021-03-19
00840118116886ZERO Profile Interlocking Cortex Screw, 3.5mm x 26mm, T15, Flex-Thread™8525-26-S2021-03-19
00840118116893ZERO Profile Interlocking Cortex Screw, 3.5mm x 28mm, T15, Flex-Thread™8525-28-S2021-03-19
00840118116909ZERO Profile Interlocking Cortex Screw, 3.5mm x 30mm, T15, Flex-Thread™8525-30-S2021-03-19
00840118116916ZERO Profile Interlocking Cortex Screw, 3.5mm x 32mm, T15, Flex-Thread™8525-32-S2021-03-19
00840118116923ZERO Profile Interlocking Cortex Screw, 3.5mm x 34mm, T15, Flex-Thread™8525-34-S2021-03-19
00840118116930ZERO Profile Interlocking Cortex Screw, 3.5mm x 36mm, T15, Flex-Thread™8525-36-S2021-03-19
00840118116947ZERO Profile Interlocking Cortex Screw, 3.5mm x 38mm, T15, Flex-Thread™8525-38-S2021-03-19
00840118116954ZERO Profile Interlocking Cortex Screw, 3.5mm x 40mm, T15, Flex-Thread™8525-40-S2021-03-19
00840118116961ZERO Profile Interlocking Cortex Screw, 3.5mm x 42mm, T15, Flex-Thread™8525-42-S2021-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
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00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017560A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017577A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017584A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00810030811657InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
00810030811671InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTW2026-06-01
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05