Stabilis™
GUDID 00846832005345
TORNIER, INC.
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00846832005345 |
| NIH Device Record Key | ec0bbc50-dfda-4022-b556-ebbd486cc97c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stabilis™ |
| Version Model Number | AFPSC4522 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 22 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832005345 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090139
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
[00846832005345]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-25 |
On-Brand Devices [Stabilis™]
| 00846832011414 | AFPCPTR |
| 00846832011407 | AFPCPLTR |
| 00846832011391 | AFPCPCR |
| 00846832011384 | AFPCPATR |
| 00846832005543 | AFPW |
| 00846832005536 | AFPTTL |
| 00846832005529 | AFPTTH |
| 00846832005499 | AFPTTC |
| 00846832005482 | AFPSC4565 |
| 00846832005475 | AFPSC4560 |
| 00846832005468 | AFPSC4555 |
| 00846832005451 | AFPSC4550 |
| 00846832005444 | AFPSC4545 |
| 00846832005437 | AFPSC4540 |
| 00846832005420 | AFPSC4538 |
| 00846832005413 | AFPSC4536 |
| 00846832005406 | AFPSC4534 |
| 00846832005390 | AFPSC4532 |
| 00846832005383 | AFPSC4530 |
| 00846832005376 | AFPSC4528 |
| 00846832005369 | AFPSC4526 |
| 00846832005352 | AFPSC4524 |
| 00846832005345 | AFPSC4522 |
| 00846832005338 | AFPSC4520 |
| 00846832005321 | AFPSC4518 |
| 00846832005314 | AFPSC4516 |
| 00846832005307 | AFPSC4514 |
| 00846832005000 | AFPCPT |
| 00846832004997 | AFPCPLT |
| 00846832004980 | AFPCPC |
| 00846832004973 | AFPCPAT |
| 00846832004935 | AFPAUG |
| 00846832004928 | AFPATTL |
| 00846832004911 | AFPATTH |
Trademark Results [Stabilis]
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