Primary Device ID | G611BIO112090 |
NIH Device Record Key | 634ee2ed-39d9-4e28-9a9c-2f5d00d298cd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Alliant Biotech |
Version Model Number | BIO-1-1209 |
Catalog Number | BIO-1-1209 |
Company DUNS | 119198202 |
Company Name | MEDISURGE 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 |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com | |
Phone | 8883071144 |
mmorrissey@medisurge.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G611BIO112090 [Primary] |
HTF | Curette |
Steralize Prior To Use | true |
Device Is Sterile | false |
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
[G611BIO112090]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-27 |
Device Publish Date | 2024-08-19 |
G611220811261500 | Symmetric Total Knee Coated Revision Stem Size 26x150 |
G6112203013550 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x35 |
G6112203013050 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x30 |
G6112203011870 | Symmetric Total Knee Ultracongruent Tibial Insert Size 7x18 |
G6112203002070 | Symmetric Total Knee Standard Tibial Insert Size 7x20 |
G6112203001870 | Symmetric Total Knee Standard Tibial Insert Size 7x18 |
G6112203001460 | Symmetric Total Knee Standard Tibial Insert Size 6x14 |
G61122021260 | Symmetric Total Knee Tibial Tray Size 6 |
G6112201021050 | Symmetric Total Knee Femoral Component Size 5 Right |
G6112201020050 | Symmetric Total Knee Femoral Component Size 5 Left |
G611WF110070 | Cancellous Bone Screw Size 6.5mm x 45mm |
G61122051024650 | Symmetric Total Knee Metaphyseal Stem Size 24x65 |
G61122051022600 | Symmetric Total Knee Metaphyseal Stem Size 22x60 |
G6112203012540 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x25 |
G6112203011840 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x18 |
G6112203011440 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x14 |
G6112203011250 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x12 |
G6112203001650 | Symmetric Total Knee Standard Tibial Insert Size 5x16 |
G6112203001450 | Symmetric Total Knee Standard Tibial Insert Size 5x14 |
G6112201020040 | Symmetric Total Knee Femoral Component Size 4 Left |
G6112201020030 | Symmetric Total Knee Femoral Component Size 3 Left |
G6112201021070 | Symmetric Total Knee Femoral Component Size 7 Right |
G6112201021060 | Symmetric Total Knee Femoral Component Size 6 Right |
G6112201021040 | Symmetric Total Knee Femoral Component Size 4 Right |
G6112201021030 | Symmetric Total Knee Femoral Component Size 3 Right |
G6112201020070 | Symmetric Total Knee Femoral Component Size 7 Left |
G6112201020060 | Symmetric Total Knee Femoral Component Size 6 Left |
G61122021270 | Symmetric Total Knee Tibial Tray Size 7 |
G61122021250 | Symmetric Total Knee Tibial Tray Size 5 |
G61122021240 | Symmetric Total Knee Tibial Tray Size 4 |
G61122021230 | Symmetric Total Knee Tibial Tray Size 3 |
G6112203001470 | Symmetric Total Knee Standard Tibial Insert Size 7x14 |
G6112203001440 | Symmetric Total Knee Standard Tibial Insert Size 4x14 |
G6112203001430 | Symmetric Total Knee Standard Tibial Insert Size 3x14 |
G6112203001270 | Symmetric Total Knee Standard Tibial Insert Size 7x12 |
G6112203001260 | Symmetric Total Knee Standard Tibial Insert Size 6x12 |
G6112203001250 | Symmetric Total Knee Standard Size 5x12 |
G6112203001240 | Symmetric Total Knee Standard Tibial Insert Size 4x12 |
G6112203001230 | Symmetric Total Knee Standard Tibial Insert Size 3x12 |
G6112203001070 | Symmetric Total Knee Standard Tibial Insert Size 7x10 |
G6112203001060 | Symmetric Total Knee Standard Tibial Insert Size 6x10 |
G6112203001050 | Symmetric Total Knee Standard Tibial Insert Size 5x10 |
G6112203001040 | Symmetric Total Knee Standard Tibial Insert Size 4x10 |
G6112203001030 | Symmetric Total Knee Standard Tibial Insert Size 3x10 |
G6112203011070 | Symmetric Total Knee Ultracongruent Tibial Insert Size 7x10 |
G6112203011060 | Symmetric Total Knee Ultracongruent Tibial Insert Size 6x10 |
G6112203011050 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x10 |
G6112203011040 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x10 |
G6112203011030 | Symmetric Total Knee Ultracongruent Tibial Insert Size 3x10 |
G6112203002060 | Symmetric Total Knee Standard Tibial Insert Size 6x20 |