FDA.report

Hip Instruments

Primary DI
07630345717849
Brand
Hip Instruments
Company
Medacta International SA
Model
20.00002
Device description
AMIS Nozzle - Instrument set EASYMIX
Published
2022-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630345717849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630345717849076303457178497630345717849

GMDN Terms

TermDefinition
Orthopaedic cement injection cannulaA sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
488227125
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
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 DIBrandModelCatalogPublished
07630542779244Surgical Manual Instrument03.52.10.08042026-03-24
07630542715303Orthopedic Manual Surgical Instrument01.10.10.34592025-10-08
07630542715310Orthopedic Manual Surgical Instrument01.10.10.34602025-10-08
07630542715327Orthopedic Manual Surgical Instrument01.10.10.34612025-10-08
07630542715334Orthopedic Manual Surgical Instrument01.10.10.34622025-10-22
07630542789984Surgical Manual Instrument02.12.10.31252026-03-19
07630542789991Surgical Manual Instrument02.12.10.31262026-03-19
07630542797576Surgical Manual Instrument02.12.10.31422026-03-19
07630699705486Surgical Manual Instrument02.12.10.31622026-03-19
07630699705493Surgical Manual Instrument02.12.10.31632026-03-19
07630699705509Surgical Manual Instrument02.12.10.31642026-03-19
07630699705516Surgical Manual Instrument02.12.10.31652026-03-19
07630699705523Surgical Manual Instrument02.12.10.31662026-03-19
07630542725562Surgical Manual Instrument01.10.10.11602026-03-17
07630542791482Spine Instruments03.75.10.06612026-03-13
07630971230880Surgical Manual Instrument03.51.10.02342026-03-02
07630542790799Mfinity Femoral System01.24.10.3002026-02-27
07630542790805Mfinity Femoral System01.24.10.3012026-02-27
07630542790812Mfinity Femoral System01.24.10.3022026-02-27
07630542790829Mfinity Femoral System01.24.10.3032026-02-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G453CFK1000PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-23
G453AR130PEAK MEDICALPeak Medical Distribution Inc.GEA2026-03-11
00810130456109Medco ManufacturingMedco Manufacturing LLCGEA2026-02-27
00850080243145T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243152T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
00850080243169T-Han Delivery SystemBONE SOLUTIONS, INC.GEA2026-02-13
20860002896964TalarusCannuflow, Inc.GEA2026-01-28
04058749082937NAFehling Instruments GmbH & Co. KGGEA2026-01-28
00840329836795N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
07630542741012CannulaMedacta International SAGEA2026-01-16
07630542741029CannulaMedacta International SAGEA2026-01-16
07630542741036CannulaMedacta International SAGEA2026-01-16
07630542746499CannulaMedacta International SAGEA2026-01-16
07630542746505CannulaMedacta International SAGEA2026-01-16
07630542746512CannulaMedacta International SAGEA2026-01-16
00840329836375N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836382N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836399N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836405N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836412N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836429N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836443N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836450N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836467N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836474N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836481N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836498N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836504N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15
00840329836542N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-15