Primary Device ID | D85463250AS1 |
NIH Device Record Key | cd95b4c3-eae6-4309-b9c9-4a62e489e280 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SML |
Version Model Number | 63250AS |
Company DUNS | 066642729 |
Company Name | SELANE PRODUCTS, 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 | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D85463250AS1 [Primary] |
LQZ | Device, Jaw Repositioning |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-08-04 |
D85466030S1 | ADD C.P.A.P-PRO |
D85463760VHS1 | ZYPPAH VH |
D85463760TS1 | ZYPPAH V W/ THERMACRYL |
D85463760TES1 | ZYPPAH T |
D85463760S1 | ZYPPAH-V |
D85463760KS1 | ZYPPAH-K |
D85463760HLS1 | ZYPPAH HL |
D85463760AS1 | ZYPPAH A |
D85463750S1 | GREENBURG SNORE-NO-MORE |
D85463725S1 | LAMBERG SLEEP WELL DEVICE |
D85463725PMTS1 | LAMBERG SLEEP WELL-PMT BASE |
D85463725AS1 | LAMBERG SLEEP WELL- ACRYLIC |
D85463603WS1 | FULL BREATH-ADJ. PTR / ACRYLIC |
D85463603PMTS1 | FULL BREATH-UPPER/PMT BASE |
D85463603NS1 | FULL BREATH-NO SNORE / ACRYLIC |
D85463603LS1 | FULL BREATH LOWER-THERMAL ACY W/ PTR |
D85463603L1 | FULL BREATH LOWER-THERMAL ACY W/ PTR |
D85463603AS1 | FULL BREATH UPPER THERMAL ACRYLIC |
D85463603AO2S1 | FULL BREATH-THERMAL W/02 TUBES |
D85463603ALCS1 | FULL BREATH LOWER ACRYLIC W/ CLASPS |
D85463603ACO2S1 | FULL BREATH--W/02 TUBES AND BALL CLASPS |
D85463603AAS1 | FULL BREATH-ALL ACRYLIC |
D85463603AAO2S1 | FBS-ACRYLIC W/02 TUBES - NO CLASPS |
D85463603AACS1 | FULL BREATH-UPPER ACRYLIC W/CLASPS |
D85463400TS1 | OASYS THERMAL ACRYLIC |
D85463400S1 | OASYS-DUAL LAMINATE |
D85463320S1 | E.M.A. |
D85463316S1 | TAP 3 |
D85463316GS1 | TAP 3 GREENBURG STYLE |
D85463316ES1 | TAP 3 ELITE |
D85463316EAS1 | TAP 3 ELITE ACRYLIC W/ CLASPS |
D85463316AS1 | TAP 3 W/ ACRYLIC & BALL CLASPS |
D85463313S1 | TAP-TL |
D85463312S1 | TAP/TALON |
D85463310S1 | TAP/ACRYLIC & CLASPS |
D85463300S1 | TAP APPLIANCE |
D85463280S1 | Z-QUIET PRO |
D85463280AS1 | Z QUIET ACRYLIC W/ CLASPS |
D85463270S1 | THERMOFORMED M.R.A. |
D85463260S1 | SILENT NIGHT APPLIANCE |
D85463252S1 | ADJUSTABLE HERBST HINGE |
D85463251S1 | UCLA MOD. HERBST-ONE SEGMENT U OR L |
D85463250TS1 | UCLA MOD.HERBST/TALON |
D85463250SLS1 | UCLA ADJ MODIFIED HERBST SL |
D85463250S1 | UCLA (CLARK) MOD HERBST |
D85463250PS1 | PMT BASED MODIFIED HERBST |
D85463250AS1 | UCLA ADJUSTABLE MODIFIED HERBST |
D85463250AHS1 | HERBST ZYPPAH HYBRID |
D85463226S1 | ADJUSTABLE DORSAL/PMT |
D85463225AS1 | ADJUSTABLE DORSAL-ACRYLIC |