Primary Device ID | 00857676008607 |
NIH Device Record Key | 84a4cd26-4a77-4e7c-b774-e7cbc99c61a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Threaded Trimmable Fixation Nail H/W Instrument Pack |
Version Model Number | H/W Pack |
Catalog Number | 967-001 |
Company DUNS | 084330422 |
Company Name | Eca Medical Instruments |
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 | true |
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 | 00857676008607 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-03 |
Device Publish Date | 2024-05-24 |
00857676008591 - Palm Handle, 2 mm Hex Torque Limiting Instrument | 2024-06-03 |
00857676008607 - Threaded Trimmable Fixation Nail H/W Instrument Pack | 2024-06-03 |
00857676008607 - Threaded Trimmable Fixation Nail H/W Instrument Pack | 2024-06-03 |
00857676008614 - Threaded Trimmable Fixation Nail F/A Instrument Pack | 2024-06-03 |
00857676008621 - Threaded Trimmable Fixation Nail Sizing Guide Pack | 2024-06-03 |
00857676008553 - iFUSE INTRA X Mallet | 2024-03-26 |
00857676008560 - iFUSE INTRA X Assist | 2024-03-26 |
00857676008577 - Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm | 2024-03-26 |
00857676008584 - Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm | 2024-03-26 |