Primary Device ID | 00811714035918 |
NIH Device Record Key | aa1d12bc-5536-4739-acec-d00be37e6701 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Superhawk |
Version Model Number | 908007-0475-P01 |
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 | 00811714035918 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
[00811714035918]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-12 |
Device Publish Date | 2024-03-04 |
00811714035321 | Superhawk Suture Anchor |
00811714035314 | Superhawk Suture Anchor |
00811714035468 | Superhawk Broach 3.75 |
00811714035451 | Superhawk Drill 3.75 Cannulated |
00811714035444 | Superhawk Drill 3.75 |
00811714035437 | Superhawk Drill Guide Circle |
00811714035079 | Superhawk Broach 4.75 |
00811714034980 | Superhawk Drill 4.75 |
00811714034959 | Superhawk Guide Wire Short |
00811714034935 | Superhawk Drill Guide Insert |
00811714034904 | Superhawk Drill 4.75 Cannulated |
00811714035086 | Superhawk Instrument Set |
00811714035819 | Superhawk Surgical Drill 3.5mm |
00811714035840 | Superhawk 3.0mm Drill |
00811714035833 | Superhawk Circle Drill Guide |
00811714035499 | Superhawk Guide Wire Short |
00811714035918 | Superhawk Broach 4.75 - Packaged |
00811714035901 | Superhawk Broach 3.75 - Packaged |