Shadow Knotless 920002-0000-P

GUDID 00811714035888

Shadow Knotless Instruments

RESPONSIVE ORTHOPEDICS LLC

Instrument tray, reusable
Primary Device ID00811714035888
NIH Device Record Key4b5290ef-5577-4475-8224-85af6b778b6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameShadow Knotless
Version Model Number920002-0000-P
Catalog Number920002-0000-P
Company DUNS002745858
Company NameRESPONSIVE ORTHOPEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811714035888 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


[00811714035888]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-14
Device Publish Date2023-11-06

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

00811714036144 - Superhawk2025-05-22 Superhawk 3.75mm/4.75mm Suture Anchors
00811714036151 - Superhawk2025-05-22 Superhawk 3.75mm End Suture Anchor
00811714036168 - Superhawk2025-05-22 Superhawk Instrument Tray
00811714036199 - Superhawk2025-05-22 Superhawk Drill 3.5mm
00811714036205 - Superhawk2025-05-22 Superhawk Cannulated Drill 3.0mm
00811714036212 - Superhawk2025-05-22 Superhawk Drill 3.0mm
00811714036229 - Superhawk2025-05-22 Superhawk Cannulated Drill 3.5mm
00811714036236 - Superhawk2025-05-22 Superhawk Guidewire 150mm Length

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