Primary Device ID | 00811714032658 |
NIH Device Record Key | 85e3f760-3ee6-4442-873b-8874e4c1d612 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spirit PEEK |
Version Model Number | 900005-0000 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811714032658 [Primary] |
FSM | Tray, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
[00811714032658]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-24 |
Device Publish Date | 2022-03-16 |
00811714035383 | Spirit PEEK Guide Wire Standard |
00811714034638 | Spirit PEEK Screwdriver |
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 |