Primary Device ID | 07899258663258 |
NIH Device Record Key | f317364b-43ed-4842-84a1-a74ed4cda809 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACCESS FIT |
Version Model Number | RIGHT SUTURE PASSER |
Catalog Number | 359-210 |
Company DUNS | 900865213 |
Company Name | GM DOS REIS INDUSTRIA E COMERCIO LTDA |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07899258663258 [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 | 2024-08-21 |
Device Publish Date | 2024-08-13 |
07899258663265 | ACCESS FIT – LEFT SUTURE PASSER |
07899258663258 | ACCESS FIT – RIGHT SUTURE PASSER |
07899258663241 | ACCESS FIT – STRAIGHT SUTURE PASSER |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCESS FIT 97433853 not registered Live/Pending |
Hoang, Jason 2022-05-29 |
ACCESS FIT 90169241 not registered Live/Pending |
Joshua Treisman 2020-09-09 |