Primary Device ID | 10851766006099 |
NIH Device Record Key | ae6cb016-c61e-44c7-a162-00e9c72c71dc |
Commercial Distribution Discontinuation | 2017-08-01 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | PERL Localization Device |
Version Model Number | R2020 |
Company DUNS | 965352946 |
Company Name | FOCAL THERAPEUTICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Needle Gauge | 17 Gauge |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851766006092 [Primary] |
GS1 | 10851766006099 [Package] Contains: 00851766006092 Package: Shelf Carton [5 Units] Discontinued: 2017-08-01 Not in Commercial Distribution |
GDF | Guide, Needle, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-04-05 |
10851766006242 - PERL Localization Device, 16Ga x 11.5cm Needle | 2019-07-24 PERL Localization Device, 16Ga x 11.5cm Needle |
00851766006115 - BioZorb LP Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds |
00851766006122 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r |
00851766006139 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r |
00851766006146 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r |
00851766006153 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds r |
00851766006160 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds |
00851766006177 - BioZorb Marker GOLD | 2018-07-09 The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds |