Primary Device ID | 00811714032597 |
NIH Device Record Key | e9ee2863-949e-41c7-b521-9bdeb24f1aff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spirit PEEK |
Version Model Number | 900001-0900 |
Company DUNS | 002745858 |
Company Name | RESPONSIVE ORTHOPEDICS LLC |
Device Count | 1 |
DM Exempt | false |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811714032597 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
[00811714032597]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-23 |
Device Publish Date | 2022-03-15 |
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00811714032627 | Spirit PEEK Tap 12mm |
00811714032610 | Spirit PEEK Tap 11mm |
00811714032603 | Spirit PEEK Tap 10mm |
00811714032597 | Spirit PEEK Tap 9mm |
00811714032580 | Spirit PEEK Tap 8mm |
00811714032573 | Spirit PEEK Tap 7mm |
00811714032658 | Spirit PEEK Instrument Set |