Primary Device ID | M944SAFB60 |
NIH Device Record Key | 4dba33d3-9fc1-4b58-8d19-199707e80c2a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SA-FB6 |
Version Model Number | SA-FB6 |
Company DUNS | 024882552 |
Company Name | WEXLER SURGICAL, 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 | 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 |
---|---|
GS1 | 00840240937540 [Secondary] |
HIBCC | M944SAFB60 [Primary] |
EQJ | Bur, Ear, Nose And Throat |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-24 |
Device Publish Date | 2025-02-14 |
00840240937618 - SA-C-FB4L | 2025-02-24 |
00840240937571 - SA-C-FB5 | 2025-02-24 |
00840240937557 - SA-DB1L | 2025-02-24 |
00840240937533 - SA-DB2L | 2025-02-24 |
00840240937649 - SA-DB3 | 2025-02-24 |
00840240937625 - SA-DB3L | 2025-02-24 |
00840240937656 - SA-DB4 | 2025-02-24 |
00840240937632 - SA-DB4L | 2025-02-24 |