| Primary Device ID | D85463250PS1 |
| NIH Device Record Key | cfe55f76-3932-4bfd-8edb-9f4007014241 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SML |
| Version Model Number | 63250PS |
| 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 | D85463250PS1 [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 |