Primary Device ID | 00850052601041 |
NIH Device Record Key | 3feed46e-c245-4141-8190-b14c2472bb9d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Suture Passer - Single Loop |
Version Model Number | DM-4890 |
Catalog Number | DM-4890 |
Company DUNS | 079471560 |
Company Name | DUNAMIS MEDICAL, 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 | true |
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 | true |
OTC Over-The-Counter | false |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com | |
Phone | 334-371-6280 |
info@dunamismedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850052601041 [Primary] |
HWQ | Passer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-25 |
Device Publish Date | 2023-08-17 |
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00850052601096 - CMC Guide | 2024-06-18 CMC Guide |