Polar E0016144-1
GUDID 00885556726273
POLAR STEM INSERTER
Smith & Nephew, Inc.
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00885556726273 |
| NIH Device Record Key | 8fa728bb-b9ad-43bc-97b5-8a0edf97b76d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polar |
| Version Model Number | E0016144-1 |
| Catalog Number | E0016144-1 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556726273 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123598
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
[00885556726273]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2018-09-12 |
On-Brand Devices [Polar]
| 00885556737767 | POLAR STEM INSERTER |
| 00885556737750 | POLAR STEM INSERTER |
| 00885556737590 | POLAR KNOCK PLATE WITH THREADED HOLE |
| 00885556735626 | EXTENDED POLAR KNOCK PLATE |
| 00885556734759 | FEMORAL OSTEOTOMY RULER |
| 00885556732410 | POLAR CALCAR PLANER - 45MM |
| 00885556732403 | POLAR CALCAR PLANER - 40MM |
| 00885556732168 | POLAR CURVED OSTEOTOME |
| 00885556732151 | POLAR CHILI PEPPER |
| 00885556731994 | POLAR STEM INSERTER |
| 00885556731550 | RAT TAIL RASP |
| 00885556731543 | STARTER BROACH |
| 00885556731536 | CURVED BOX OSTEOTOME |
| 00885556726273 | POLAR STEM INSERTER |
| 00885556725757 | POLAR CALCAR PLANER - 45MM |
| 00885556725740 | POLAR CALCAR PLANER - 40MM |
| 00885556722770 | MODULAR POLAR BOX OSTEOTOME |
| 00885556722763 | MODULAR POLAR BOX OSTEOTOME |
| 00885556721377 | POLAR CALCAR PLANER - 45MM |
| 00885556721360 | POLAR CALCAR PLANER - 40MM |
| 00885556721353 | POLAR CALCAR PLANER - 45MM |
| 00885556721346 | POLAR CALCAR PLANER - 40MM |
| 00885556720974 | FEMORAL OSTEOTOMY RULER |
| 00885556719275 | MODULAR POLAR BOX OSTEOTOME |
| 00885556717882 | MODIFIED 28MM INSERT |
| 00885556717875 | MODIFIED 22MM INSERT |
| 00885556717868 | MODIFIED POLAR CUP INSERTER |
| 00885556717288 | MODULAR POLAR BOX OSTEOTOME |
| 00885556716779 | POLAR BOX OSTEOTOME |
| 00885556715611 | POLAR CALCAR PLANER - 45MM |
| 00885556715604 | POLAR CALCAR PLANER - 40MM |
| 00885556715574 | POLAR CALCAR PLANER - 45MM |
| 00885556715567 | POLAR CALCAR PLANER - 40MM |
| 00885556715550 | POLAR CURVED OSTEOTOME |
| 00885556709924 | POLAR CANAL FINDER |
| 00885556709917 | POLAR BOX OSTEOTOME |
| 00885556707913 | OFFSET POLAR STEM INSERTER |
| 00885556707777 | MODULAR POLAR STARTER BROACH |
| 00885556707760 | MODULAR POLAR BOX OSTEOTOME |
| 00885556707272 | REDUCED DUAL OFFSET BROACH HANDLE RT |
| 00885556707265 | REDUCED DUAL OFFSET BROACH HANDLE LT |
| 00885556706282 | POLAR STEM INSERTER W/VERSION CONTROL |
| 00885556701577 | POLAR CALCAR PLANER - 36MM |
| 00885556701560 | POLAR CALCAR PLANER - 45MM |
| 00885556701553 | POLAR CALCAR PLANER - 40MM |
| 00885556699836 | LARGE POSTERIOR RETRACTOR |
| 00885556698464 | POLAR TO ANTHOLOGY ADAPTER |
| 00885556697399 | POLAR CURVED BOX OSTEOTOME |
| 00885556697177 | POLAR STARTER BROACH |
| 00885556697160 | POLAR CALCAR ADAPTER POST |
Trademark Results [Polar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLAR 98821579 not registered Live/Pending |
Huang, Ling 2024-10-25 |
 POLAR 98784802 not registered Live/Pending |
Entrans International, LLC 2024-10-03 |
 POLAR 98205293 not registered Live/Pending |
South 8 Technologies, Inc. 2023-10-01 |
 POLAR 98166588 not registered Live/Pending |
RubberTopUSA, LLC 2023-09-06 |
 POLAR 98117131 not registered Live/Pending |
TRIGGA LTD 2023-08-04 |
 POLAR 98117118 not registered Live/Pending |
TRIGGA LTD 2023-08-04 |
 POLAR 97928916 not registered Live/Pending |
AKA Holdings LLC 2023-05-10 |
 POLAR 97912220 not registered Live/Pending |
Polar Industria de Plásticos SA 2023-04-28 |
 POLAR 97839915 not registered Live/Pending |
Ridgeline International, Inc. 2023-03-15 |
 POLAR 97098657 not registered Live/Pending |
NFT Technology Inc 2021-10-29 |
 POLAR 90773930 not registered Live/Pending |
Norcold, Inc. 2021-06-15 |
 POLAR 90726690 not registered Live/Pending |
CLAM CORPORATION 2021-05-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.