Reference Source

Jurdas · 89-08 · LITHUANIA

For Jurdas, import alert is 89-08; country is LITHUANIA; 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 Peni Master Pro Device | Peni Master Pro Device | Peni Master Pro Device | Peni Master Pro Device; product code is 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 78 L - - KY Device, External Penile Rigidity; date published is 08/25/2017; address is Savanoriu pr. 65-2 , Vilnius, Vilniaus LITHUANIA, verified against its source on 2026-09-30.

Firm
Jurdas 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
LITHUANIA verified
Address
Savanoriu pr. 65-2 , Vilnius, Vilniaus LITHUANIA verified
Date published
08/25/2017 verified
Product code
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 78 L - - KY Device, External Penile Rigidity each item verified
Product
Peni Master Pro Device | Peni Master Pro Device | Peni Master Pro Device | Peni Master Pro Device each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Jurdas Date Published : 08/25/2017 Savanoriu pr. 65-2 , Vilnius, Vilniaus LITHUANIA

— 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 and Product

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 08/25/2017 Desc: Peni Master Pro Device 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 08/25/2017 Desc: Peni Master Pro Device 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 08/25/2017 Desc: Peni Master Pro Device 78 L - - KY Device, External Penile Rigidity Date Published: 08/25/2017 Desc: Peni Master Pro Device

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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