Primary Device ID | B235MDK00020 |
NIH Device Record Key | 72fd18dc-6ecd-4caf-a3f2-41a6b711c158 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | mild Device Kit |
Version Model Number | MDK-0002 |
Company DUNS | 196548481 |
Company Name | STRYKER CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 |
---|---|
HIBCC | B235MDK00020 [Primary] |
HRX | Arthroscope |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-08-07 |
Device Publish Date | 2024-06-19 |
B235MDK00020 - mild Device Kit | 2025-08-07 |
B235MDK00020 - mild Device Kit | 2025-08-07 |
07613327262995 - XIA II | 2025-07-17 CORONAL BENDER LEFT |
07613327263015 - XIA II | 2025-07-17 CORONAL BENDER RIGHT |
07613327661989 - KNOTILUS+ | 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
07613327661996 - KNOTILUS+ | 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
07613327662009 - KNOTILUS+ | 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |
07613327662016 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE |
07613327662023 - KNOTILUS+ | 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE |