Primary Device ID | M595S4043 |
NIH Device Record Key | 23b45f9d-94eb-41b9-ba23-94a5e2874802 |
Commercial Distribution Discontinuation | 2019-01-01 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | TriPhasix™ |
Version Model Number | S400 |
Catalog Number | S400 |
Company DUNS | 009900424 |
Company Name | PARKELL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 |
Phone | 6312491134 |
customerservice@parkell.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place. |
Special Storage Condition, Specify | Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M595S4000 [Primary] |
HIBCC | M595S4011 [Package] Contains: M595S4000 Package: [5 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
HIBCC | M595S4022 [Package] Contains: M595S4000 Package: [10 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
HIBCC | M595S4043 [Package] Contains: M595S4000 Package: [25 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-04-01 |
Device Publish Date | 2016-09-23 |
30810000526155 | 1lb. TriPhasix™ Chromatic Alginate |
M595S4043 | 1lb. TriPhasix™ Chromatic Alginate |
10810000526182 | Measuring Scoops TriPhasix™ Alginate (2 each) |
00810000528271 | Measuring Scoops TriPhasix™ Alginate |