Primary Device ID | D813SPD13250 |
NIH Device Record Key | 1096f131-bac3-4ae1-a1b1-701759af03ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Splash® |
Version Model Number | SPD1325 |
Catalog Number | SPD1325 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
Device Count | 25 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com | |
Phone | 18004336628 |
info@denmat.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813SPD13250 [Unit of Use] |
HIBCC | D813SPD13251 [Primary] |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-30 |
Device Publish Date | 2022-09-22 |
D813SPD15941 | SPLASH BULK PACK HT HVY BRY |
D813SPD15931 | SPLASH BULK PACK HT MED BRY |
D813SPD15921 | SPLASH 8PK HT LITE BRY |
D813SPD15911 | SPLASH 8PK HT XLITE BRY |
D813SPD15901 | SPLASH BLK PK REG HVY BRY |
D813SPD15891 | SPLASH BLK PK REG MED BRY |
D813SPD15881 | SPLASH 8PK REG LITE BRY |
D813SPD15871 | SPLASH 8PK REG XLITE BRY |
D813SPD15600 | SPLASH JUMBO CART REFILL MED |
D813SPD15590 | SPLASH JUMBO CART REFILL HVY |
D813SPD15320 | SPLASH FATPAK INTRO MED |
D813SPD15310 | SPLASH FATPAK INTRO HVY |
D813SPD15300 | SPLASH FATPAK REFILL MED |
D813SPD15290 | SPLASH FATPAK REFILL HVY |
D813SPD13501 | SPLASH PTY HT SET BLK BX 200pc |
D813SPD12501 | SPLASH PTY PK REG SET BX 400pc |
D813SPD12371 | SPLASH HT PTY PK BRY |
D813SPD12350 | SPLASH HT JAR PTY BRY |
D813SPD12330 | SPLASH CART HT SET HVY BRY |
D813SPD12320 | SPLASH HT CART SET MED BRY |
D813SPD12310 | SPLASH HT CART SET LITE BRY |
D813SPD12300 | SPLASH HT CART SET XLITE BRY |
D813SPD12190 | SPLASH PTY PAK REG SET BRY |
D813SPD12120 | SPLASH PTY JAR REG SET BRY |
D813SPD12110 | SPLASH CART REG SET HVY BRY |
D813SPD12100 | SPLASH CART REG SET MED BRY |
D813SPD12090 | SPLASH CART REG SET LITE BRY |
D813SPD12080 | SPLASH CART REG SET XLITE BRY |
D813SPD19080 | SPLASH XLITE REG CART 3pc |
D813SPD19070 | SPLASH LITE REG CART 5pc |
D813SPD19060 | SPLASH MEDIUM REG CART 5pc |
D813SPD19050 | SPLASH HEAVY REG CART 5pc |
D813SPD19040 | SPLASH XLITE HT CART 3pc |
D813SPD19030 | SPLASH LITE HT CART 5pc |
D813SPD19020 | SPLASH MEDIUM HT CART 5pc |
D813SPD19010 | SPLASH HEAVY HT CART 5pc |
D813SPD19000 | SPLASH MED HT 10pc w/12 MXTIPS |
D813SPD15280 | FATPAK BAG OF TIPS SPLSH&PREC |
D813SPD13250 | PF TMP MIX GOLD TIPS 25PK |
D813SPD11900 | TIPS IO WHITE 50pc |
D813SPD11840 | SP IO TIPS CLEAR 50PK |
D813SPD11830 | SP MIX TIP TEAL 50PK |
D8132222851 | SP 10 TIPS WHT 6PK |
D8131115100 | TIP JUMBO CART SPLSH/PREC 25pc |