Primary Device ID | 00840118112079 |
NIH Device Record Key | c7716e47-d63c-44b7-a4fa-ef088a09e57c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flower E-Kit, Advanced |
Version Model Number | EWK 201 |
Company DUNS | 078790947 |
Company Name | FLOWER ORTHOPEDICS CORPORATION |
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 | 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 | 00840118112079 [Primary] |
HTY | Pin, Fixation, Smooth |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2018-05-02 |
00840118121774 - Flower Orthopedics | 2024-06-10 Double Drill Guide- 2.8/4.0mm |
00840118125024 - Flower Orthopedics | 2024-06-10 Flower K-Wire S, 0.8mm, sterile, single use (2 pieces) |
00840118125031 - Flower Orthopedics | 2024-06-10 Flower Drill Guide S, D:1.5mm, sterile, single use |
00840118125055 - Flower Orthopedics | 2024-06-10 Flower Torque Bit S, sterile, single use |
00840118125062 - Flower Orthopedics | 2024-06-10 Flower K-Wire XS, 0.6mm, sterile, single use (2 pieces) |
00840118125079 - Flower Orthopedics | 2024-06-10 Flower Drill S, D:1.5mm, sterile, single use |
00840118125086 - Flower Orthopedics | 2024-06-10 Flower K-Wire Applicator, sterile |
00840118125093 - Flower Orthopedics | 2024-06-10 Flower Peek K-Wire Applicator (PWA), sterile |