Primary Device ID | D813BLSR30060 |
NIH Device Record Key | d0f60e44-40d4-482c-91d4-4ccb1894543b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | STERLING® |
Version Model Number | BLSR3006 |
Catalog Number | BLSR3003 |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-4336628 |
info@denmat.com | |
Phone | 1-800-4336628 |
info@denmat.com |
Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813BLSR30060 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-02-28 |
Device Publish Date | 2019-01-28 |
D813BLSR30080 | LSR WIRELESS FOOTPEDAL BENCO |
D813BLSR30060 | LSR CHARGING BASE BENCO |
D813BLSR30030 | LASER UNIT BENCO |
D813BLSR1013A1 | LSR PERIO TIP 7mm 25pk BENCO |
D813BLSR1012A1 | LSR REG TIP 5mm 25pk BENCO |
D813BLSR3003L0 | BENCO LASER LOANER UNIT |