| Primary Device ID | 20811870037669 |
| NIH Device Record Key | 514c496c-7805-40be-a56b-c552ebab99f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Manus Medical, LLC |
| Version Model Number | MCK-20630 |
| Company DUNS | 800604196 |
| Company Name | Manus Medical, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811870037665 [Primary] |
| GS1 | 20811870037669 [Package] Contains: 00811870037665 Package: [20 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
[20811870037669]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-30 |
| Device Publish Date | 2023-08-22 |
| 20811870037621 | LIPOGEMS EFFICIENCY KIT TAA |
| 20811870037614 | OR Blue Towel Pack Xray 100's W/Gold Stitch Nonsterile |
| 20811870037607 | OR Blue Towel Pack Xray 1's |
| 20811870037591 | OR White Towel Pack Non Xray 1'S |
| 20811870037584 | OR Green Towel Pack Xray 2's |
| 20811870037577 | OR White Towel Pack Non Xray 2's |
| 20811870037560 | OR WHITE TOWEL PACK XRAY 6'S |
| 20811870037553 | OR Blue Towel Pack XR 8's |
| 20811870037546 | OR White Towel Pack Xray 100's Nonsterile |
| 20811870037539 | OR White Towel Pack Xray 4's |
| 20811870037522 | OR Blue Towel Pack Non Xray 4's |
| 20811870037515 | OR Blue Towel Pack Xray 4's |
| 20811870037638 | Needle View Camera Sterile Drape |
| 20811870037669 | Sterile Pacemaker Drape |
| 20811870037652 | Paracervical Pudendal Block Tray |
| 20811870037676 | SCATPAD 11" X 34" |
| 20811870037690 | Loop Insertion Tray |
| 20811870037683 | Wet Skin Prep Tray |
| 20811870037737 | GRAVES VAGINAL SPEC. SS (SMALL) |
| 20811870037720 | Econowipe 36A Cust Sup |
| 20811870037713 | NERVE BLOCK TRAY |
| 20811870037706 | STERILE VIENNA SPECULUM |
| 20811870037751 | Flushing Needle Bundles |
| 00811870037740 | WRTC PACK |
| 20811870037775 | PENROSE DRAIN .75" X 18" |
| 20811870037805 | Scatter Radiation Pad |
| 20811870037799 | Peripheral Triple Ctrscp |
| 20811870037782 | Scatpad, Dbl. Tape, 12.5" x 16.5" |
| 20811870037812 | VEIN CLOSURE TRAY W.O INTRODUCER |
| 20811870037836 | COTTON CAST PADDING 3" X 4 YDS |
| 20811870037829 | Umbilical Catheter Tray |
| 20811870037843 | VEIN CLOSURE TRAY W.O INTRODUCER |
| 20811870037874 | SINGLE SHOT EPIDURAL TRAY |
| 20811870037867 | LUMBAR PUNCTURE KIT #2 |
| 20811870037850 | SILICONE TUBING, ID 3/16" X OD 5/16" (40") |
| 20811870037898 | Combo Tray 1 & 2 |
| 20811870037959 | STEREO PACK W/CHLORAPREP |
| 20811870037942 | TUBING CLAMP 7.5" |
| 00811870037931 | TAPE, TRACH TUBE 2'S |
| 20811870037928 | THE EYE INSTITUTE OF UTAH LASIK PACK |
| 20811870037911 | BONE MARROW BIOPSY TRAY |
| 20811870037904 | LIPOGEMS EFFICIENCY KIT TAA |
| 20811870037881 | TAA EFFICIENCY KIT |
| 20811870037973 | LACERATION TRAY (FACIAL) |
| 20811870037980 | WIRE CUTTING SCISSORS 4..75" |