Primary Device ID | 07630971292116 |
NIH Device Record Key | ed8541a6-bc4d-4297-a5eb-441b5dfe99e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SportMeds Instruments |
Version Model Number | 05.05.10.0128 |
Company DUNS | 488227125 |
Company Name | Medacta International SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630971292116 [Primary] |
NBH | Accessories, Arthroscopic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
[07630971292116]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-18 |
Device Publish Date | 2021-03-10 |
07630971293212 | T-Handle Zimmer Hall connection |
07630971292147 | Cannulated drill Ø12 mm |
07630971292130 | Cannulated drill Ø11 mm |
07630971292123 | Cannulated drill Ø10 mm |
07630971292116 | Cannulated drill Ø9 mm |
07630971292109 | Cannulated drill Ø8 mm |
07630971292093 | Cannulated drill Ø7 mm |
07630971292086 | Cannulated drill Ø6 mm |
07630971281837 | Quick Connect Ratchet Handle cannulated |
07630971281813 | Cannulated Screwdriver Shaft T40 |
07630971281790 | Cannulated Screwdriver Shaft T25 |
07630971281776 | Cannulated Screwdriver Shaft T20 |
07630971238138 | Subcutaneous Cutter Large |
07630040731485 | MectaQTH Cutter Handle |
07630040731478 | Subcutaneous cutter small |
07630040731461 | Sports Medicine - PCL Tray |
07630040728836 | Tibial Aimer Bullet PCL |
07630040728317 | PCL Elevator |
07630040728300 | PCL rasp |
07630040728294 | PCL Femoral Aimer Ø7-10 |
07630971259263 | FastShuttle CC - Disposable Needle – STERILE (5x) Removable locking handle |
07630971259256 | FastShuttle CC – Suture Passer Capsule Closure Removable locking handle |
07630971258587 | All-Suture anchor - Drill Ø1.8 - Long Removable locking handle |
07630971258570 | All-Suture anchor - Drill Ø2.4 - Short Removable locking handle |
07630971258563 | All-Suture anchor - Drill Ø1.8 - Short Removable locking handle |
07630971256286 | Suture Cutter Closed WL220 Forceps Handle Removable locking handle |
07630971256279 | Suture Cutter Open WL165 Forceps Handle Removable locking handle |
07630971256262 | Suture Cutter Open WL220 Forceps Handle Removable locking handle |
07630971256255 | Suture Cutter Closed WL165 Wishbone Handle Removable locking handle |
07630971256231 | Suture Cutter Open WL165 Wishbone Handle Removable locking handle |
07630971256224 | Suture Cutter Open WL220 Wishbone Handle Removable locking handle |
07630971256217 | Suture Cutter Open WL165 Forceps Handle Locking Removable locking handle |
07630345725547 | 4.5mm Cortical Reamer Pin Removable locking handle |
07630345714121 | Slotted Aimer – Fork Tip – Long Removable locking handle |
07630345714114 | Slotted Aimer – Fishmouth Tip – Long Removable locking handle |
07630345714107 | Slotted Aimer – Crown Tip – Long Removable locking handle |
07630345714091 | Slotted Aimer – Fork Tip – Short Removable locking handle |
07630345714084 | Slotted Aimer – Fishmouth Tip – Short Removable locking handle |
07630345714077 | Slotted Aimer – Crown Tip – Short Removable locking handle |
07630345703910 | Punch – Ø6.5 Removable locking handle |
07630345703903 | Punch – Ø5.5 Removable locking handle |
07630345703897 | Punch - Ø4.5 Removable locking handle |
07630040728850 | Hip Arthro - Access Kit Removable locking handle |
07630040728287 | Tibial Aimer Adjustable Angle PCL Removable locking handle |
07630345701596 | Femoral Aimer AM Ø9-10 for cortical reamer pin |
07630345701589 | Femoral Aimer AM Ø7-8 for cortical reamer pin |
07630345703880 | PAO Screwdriver 3.5 |
07630345703873 | PAO Screwdriver 2.5 |
07630345749918 | Curved beaver blade |
07630345749901 | Straight beaver blade |