Pressure Sentinel® 00-2228-024-00
GUDID 00889024581777
Zimmer, Inc.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00889024581777 |
| NIH Device Record Key | ade4342c-fd2f-4460-9ace-dbef6aa24ee9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pressure Sentinel® |
| Version Model Number | 2228-24 |
| Catalog Number | 00-2228-024-00 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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 | true |
| 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)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
| Device Size Text, specify | 0 |
| Length | 100 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024581777 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191238
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
On-Brand Devices [Pressure Sentinel®]
Trademark Results [Pressure Sentinel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRESSURE SENTINEL 75009347 2100060 Live/Registered |
ZIMMER, INC. 1995-10-23 |
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