Primary Device ID | D813ZLR2006A1 |
NIH Device Record Key | 004ac58b-e416-4c75-843b-8461430d1218 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SL3® |
Version Model Number | ZLR2006A |
Catalog Number | ZLR2006A |
Company DUNS | 809857704 |
Company Name | DEN-MAT HOLDINGS, LLC |
Device Count | 25 |
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 | 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 | 1-800-433-6628 |
info@denmat.com | |
Phone | 1-800-433-6628 |
info@denmat.com |
Length | 7 Millimeter |
Length | 7 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D813ZLR2006A0 [Unit of Use] |
HIBCC | D813ZLR2006A1 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-09-24 |
D813ZLR2006A1 | SL3 DISP PERIO TIPS 7MM 25PK |
D813ZLR2005A1 | SL3 DISP REG TIPS 5MM 25PK |
D813ZLR20040 | SL3 FOOT PEDAL |
D813ZLR20090 | SL3 REPLACEMENT POWER SUPPLY |
D813ZLR20080 | SL3 HANDPIECE AUTOCLAVABLE |
D813ZLR20030 | SL3 UNIFIBER SYSTEM |
D813ZLR10180 | FIBERS AC-FIBER 400um 12FT |