Biotronix 2000 Inc. (Lg Technologies) · 89-08 · CANADA
For Biotronix 2000 Inc. (Lg Technologies) · 89-08 · CANADA, import alert is 89-08; 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)"; country is CANADA; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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