Primary Device ID | 03700879516455 |
NIH Device Record Key | 04e3a8a5-19a3-4cf1-aa12-d1a597a6f1f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pecaplasty® |
Version Model Number | SKW06002 |
Catalog Number | SKW06002 |
Company DUNS | 264255288 |
Company Name | NOVASTEP |
Device Count | 1 |
DM Exempt | true |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03700879516455 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-02 |
Device Publish Date | 2022-11-24 |
03700879516455 | Sterile traction wire Ø2.5 lg128 |
03700879516448 | Traction wire Ø2.5 lg128 |
03700879517612 | Targeting guide 2.0 wires first |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PECAPLASTY 97029206 not registered Live/Pending |
NOVASTEP 2021-09-15 |