Primary Device ID | M648C1002021 |
NIH Device Record Key | fc42f740-f4b0-4c4c-81df-8599a9b10086 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ELBOW CONNECTOR |
Version Model Number | C100202 |
Company DUNS | 011560431 |
Company Name | OBP CORPORATION |
Device Count | 1 |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M648C1002020 [Primary] |
HIBCC | M648C1002021 [Package] Contains: M648C1002020 Package: BAG [10 Units] In Commercial Distribution |
GAD | Retractor |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-30 |
Device Publish Date | 2020-10-22 |
M648C0601002 - ANOSPEC | 2023-11-17 90mm x 18mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
M648C0601102 - ANOSPEC | 2023-11-17 96mm x 23mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
M648C0601202 - ANOSPEC | 2023-11-17 103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
M648C1102101 - ONETRAC LXS | 2022-04-25 ONETRAC LXS SUCTION, METAL TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
M648C1102201 - ONETRAC LXS | 2022-04-25 ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
M648C1002801 - ONETRAC LX | 2021-06-10 Retractor 90x30mm with Built-In Single-Use Multi-LED Light Source - STERILE |
M648C1002901 - ONETRAC LX | 2021-06-10 Retractor 135X20mm with Built-In Single-Use Multi-LED Light Source - STERILE |
M648C1102001 - ONETRAC LXS | 2021-04-20 ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |