FDA.reportPublic FDA data

Cannula

Primary DI
06938695502254
Brand
Cannula
Company
Shanghai Kinetic Medical Co., Ltd.
Model
FG2203
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938695502254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938695502254069386955022546938695502254

GMDN Terms#

Term, Definition table
TermDefinition
Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
528198569
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938695502155Bone DrillFG27012025-12-09
06938695521026DrillFG21002025-12-09
06938695527004Bone DrillFG27002025-12-09
06938695522009CannulaFG2200FG22002016-12-05
06938695524003DilatorFG2400FG24002016-12-05
06938695530066Puncture NeedleFG3006FG30062016-05-26
06938695537676Dilator w/CannulaFG2410FG24102020-05-31
06938695546067KMC Guide Wire, 1.6mm, Blunt TipKMC-000-002020-10-01
06938695546074KMC Guide Wire, 1.6mm, Sharp TipKMC-000-102020-10-01
06938695546081KMC Access Needle, 11 Gauge, 95mm, Bevel TipKMC-001-002020-10-01
06938695546098KMC Access Needle, 11 Gauge, 95mm, Pyramid TipKMC-001-102020-10-01
06938695546104KMC Access Needle, 11 Gauge, 115mm, Pyramid TipKMC-001-112020-10-01
06938695546111KMC Access Needle, 11 Gauge, 115mm, Integrated Diamond TipKMC-001-202020-10-01
06938695546128KMC Access Needle, 11 Gauge, 115mm, Integrated Bevel TipKMC-001-302020-10-01
06938695546135KMC Access Needle, 13 Gauge, 95mm, Pyramid TipKMC-002-002020-10-01
06938695546142KMC Access Needle, 13 Gauge, 115mm, Pyramid TipKMC-002-012020-10-01
06938695546159KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel TipKMC-002-102020-10-01
06938695546166KMC Balloon Catheter, 8 Gauge, 10mmKMC-003-102020-10-01
06938695546173KMC Balloon Catheter, 8 Gauge, 15mmKMC-003-152020-10-01
06938695546180KMC Balloon Catheter, 8 Gauge, 20mmKMC-003-202020-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403249MillenniumAvalign Technologies, Inc.GEA2026-07-19
00810220800485Adler Instrument CompanyAdler, Inc.GEA2026-07-17
10810128462782StayPort™ Cannula 5 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
B382SD2303290Surgical DirectSurgical Direct, Inc.GEA2026-07-14
B382SD303490Surgical DirectSurgical Direct, Inc.GEA2026-07-14
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456604Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456611Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
00850083275709Intrace USAPILOTIS TECH LLCGEA2026-07-03
00810130456550Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00810130456567Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05