Primary Device ID | B390AR98211 |
NIH Device Record Key | de2549ee-55ed-496e-aa7b-d51baaa6cb0e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reprocessed Apollo RF Aspirating Ablator 90, Extra Large |
Version Model Number | AR-9821 |
Company DUNS | 785616934 |
Company Name | SURETEK MEDICAL |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B390AR98211 [Primary] |
NBH | Accessories, Arthroscopic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-11-06 |
Device Publish Date | 2020-10-29 |
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