Biotronix 2000 Inc. (Lg Technologies) · 89-08 · CANADA
For Biotronix 2000 Inc. (Lg Technologies), import alert is 89-08; country is CANADA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS | Sharpes Container sold with Model NX5000 SDS and alone; product code is 80 K - - ZH Introducer, Syringe Needle | 80 M - - MK Container, Sharps; date published is 01/23/2019; address is 2185 Rue Michelin , Laval, QC CANADA, verified against its source on 2026-09-30.
- Firm
- Biotronix 2000 Inc. (Lg Technologies) verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CANADA verified
- Address
- 2185 Rue Michelin , Laval, QC CANADA verified
- Date published
- 01/23/2019 verified
- Product code
- 80 K - - ZH Introducer, Syringe Needle | 80 M - - MK Container, Sharps each item verified
- Product
- Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS | Sharpes Container sold with Model NX5000 SDS and alone each item verified
- FDA notes
- 8/19/1998 | 8/19/1998 each item verified
What the source says
Biotronix 2000 Inc. (Lg Technologies) Date Published : 01/23/2019 2185 Rue Michelin , Laval, QC CANADA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
80 K - - ZH Introducer, Syringe Needle Date Published: 01/23/2019 Desc: Needlesafe; all models; including NX3000; NX2000; NX1000; NX5000 SDS Notes: 8/19/1998 80 M - - MK Container, Sharps Date Published: 01/23/2019 Desc: Sharpes Container sold with Model NX5000 SDS and alone Notes: 8/19/1998
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html