Primary Device ID | M97022000800400 |
NIH Device Record Key | 5216a36f-a0a1-4344-8354-8b3435683e30 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 4mm Drill Guide, Threaded, DynaNail |
Version Model Number | 2200-08-0040 |
Company DUNS | 601306413 |
Company Name | Medshape, Inc. |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M97022000800400 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
[M97022000800400]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-29 |
Device Publish Date | 2023-06-21 |