Primary Device ID | 00817906029482 |
NIH Device Record Key | 5bbcec27-ad39-496f-8bec-2fca7017b8bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoLink Mini |
Version Model Number | P09 N1205 |
Company DUNS | 079700711 |
Company Name | IN2BONES USA, 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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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 | 00817906029482 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00817906029482]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-07 |
Device Publish Date | 2019-09-27 |
00817906029574 | T-Plate, 7H, Trial |
00817906029567 | T-Plate, 5H, Trial |
00817906029550 | Straight Plate, 8H, Trial |
00817906029543 | Straight Plate, 6H, Trial |
00817906029536 | Straight Plate, 4H, Trial |
00817906029529 | Straight Plate, 3H, Trial |
00817906029512 | Straight Plate, 2H, Trial |
00817906029505 | Oblique L Plate, 7H, Left, Trial |
00817906029499 | Oblique L Plate, 7H, Right, Trial |
00817906029482 | Oblique L Plate, 5H, Left, Trial |
00817906029475 | Oblique L Plate, 5H, Right, Trial |
00817906029468 | T-Plate, 7H |
00817906029451 | T-Plate, 5H |
00817906029444 | Straight Plate, 8H |
00817906029437 | Straight Plate, 6H |
00817906029420 | Straight Plate, 4H |
00817906029413 | Straight Plate, 3H |
00817906029406 | Straight Plate, 2H |
00817906029390 | Oblique L Plate, 7H, Left |
00817906029383 | Oblique L Plate, 7H, Right |
00817906029376 | Oblique L Plate, 5H, Left |
00817906029369 | Oblique L Plate, 5H, Right |
00810021860329 | Locking Drill Guide, Ø1.9 |
00810021860312 | Locking Drill Guide, Ø1.6 |