ESTREMO DT030023
GUDID 08059386741948
Tissue protection sleeve with AO quick connection
CITIEFFE SRL
Surgical drill guide, reusable| Primary Device ID | 08059386741948 |
| NIH Device Record Key | fb2858e4-1700-4104-8139-ee34c4b4b491 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESTREMO |
| Version Model Number | Tissue protection sleeve AO joint |
| Catalog Number | DT030023 |
| Company DUNS | 431406875 |
| Company Name | CITIEFFE SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com | |
| Phone | +39051721850 |
| support@citieffe.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08059386741948 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181540
FDA Product Code
| HSB | Rod, Fixation, Intramedullary And Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
[08059386741948]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-18 |
| Device Publish Date | 2024-06-10 |
On-Brand Devices [ESTREMO]
| 08052990979523 | Extractor, threaded M8x1 |
| 08052990976423 | Slotted hammer |
| 08052990976188 | Kirschner wire, trocar tip ø3x350mm |
| 08051739535372 | Kirschner wire, trocar tip ø3x350mm |
| 08051739535365 | Graduated drill bit, ø4mm |
| 08051739535358 | Drill bit, ø4mm |
| 08052990976416 | Screws depth gauge |
| 08052990976355 | Nails ruler, wire 800mm |
| 08052990976348 | Template nails length |
| 08052990976331 | Screws ruler |
| 08051739531602 | Nails ruler kit with wire 1000mm |
| 08051739531596 | Nails ruler kit with wire 800mm |
| 08051739535341 | Guide wire with olive ø3x800mm |
| 08051739535631 | ESTREMO locking end cap, 10mm |
| 08051739535624 | ESTREMO locking end cap, 5mm |
| 08052990976300 | Cannula with handle |
| 08052990976294 | Cannula |
| 08052990976393 | Screws depth gauge |
| 08051739536386 | Compaction device |
| 08051739536522 | Drill bit, ø4x350mm (STERILE) |
| 08051739536416 | Drill bit, ø4x110mm (STERILE) |
| 08052990976362 | ESTREMO guide |
| 08052990976560 | ESTREMO instrument box, empty |
| 08051739535877 | ESTREMO instrument set tray, 3 empty |
| 08051739535860 | ESTREMO instrument set tray, 2 empty |
| 08052990974634 | ESTREMO locking end cap |
| 08052990974627 | ESTREMO end cap, 10mm |
| 08052990974610 | ESTREMO end cap, 5mm |
| 08052990974603 | ESTREMO end cap, standard |
| 08052990979851 | Chuck for ø3mm wires |
| 08051739535815 | Impaction bolt, cannulated |
| 08052990976287 | Cannulated awl |
| 08052990975624 | ESTREMO nail ø13x470mm |
| 08052990975617 | ESTREMO nail ø13x455mm |
| 08052990975600 | ESTREMO nail ø13x440mm |
| 08052990975594 | ESTREMO nail ø13x425mm |
| 08052990975587 | ESTREMO nail ø13x410mm |
| 08052990975570 | ESTREMO nail ø13x395mm |
| 08052990975563 | ESTREMO nail ø13x380mm |
| 08052990975556 | ESTREMO nail ø13x365mm |
| 08052990975549 | ESTREMO nail ø13x350mm |
| 08052990975532 | ESTREMO nail ø13x335mm |
| 08052990975525 | ESTREMO nail ø13x320mm |
| 08052990975518 | ESTREMO nail ø13x305mm |
| 08052990975501 | ESTREMO nail ø13x290mm |
| 08052990975495 | ESTREMO nail ø13x275mm |
| 08052990975488 | ESTREMO nail ø13x260mm |
| 08052990975457 | ESTREMO nail ø12x470mm |
| 08052990975440 | ESTREMO nail ø12x455mm |
| 08052990975433 | ESTREMO nail ø12x440mm |
Trademark Results [ESTREMO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTREMO 87940266 5669211 Live/Registered |
Estremo Fitness, Inc. 2018-05-29 |
 ESTREMO 86874693 not registered Live/Pending |
Sentury Tire USA Inc. 2016-01-13 |
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