Primary Device ID | 00840286855532 |
NIH Device Record Key | c30d01c7-d767-482b-8d19-7e30bec28382 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CS2 Acetabular System |
Version Model Number | 1800-2-1264 |
Catalog Number | 1800-2-1264 |
Company DUNS | 085976260 |
Company Name | Shalby Advanced Technologies, Inc. |
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 | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com | |
Phone | +1(916)355-7100 |
khansen@consensusortho.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840286855532 [Primary] |
KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
[00840286855532]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-28 |
Device Publish Date | 2025-05-20 |
00840286855389 | Reamer, Acetabular, 49mm |
00840286855372 | Reamer, Acetabular, 48mm |
00840286855365 | Reamer, Acetabular, 47mm |
00840286855358 | Reamer, Acetabular, 46mm |
00840286855341 | Reamer, Acetabular, 45mm |
00840286855334 | Reamer, Acetabular, 44mm |
00840286855327 | Reamer, Acetabular, 43mm |
00840286855310 | Reamer, Acetabular, 42mm |
00840286855303 | Reamer, Acetabular, 41mm |
00840286855297 | Reamer, Acetabular, 40mm |
00840286855280 | Acetabular Reamer Handle |
00840286855273 | Assembly, Impactor Shaft, Acetabular Insert Impactor |
00840286855266 | CS2, Impactor Head, Acetabular Shell Impactor |
00840286855259 | Impactor Head, Acetabular Insert, Plastic, 36mm |
00840286855235 | Impactor Head, Plastic, Acetabular Insert Impactor, 32mm |
00840286855228 | Impactor Head, Plastic, Acetabular Insert Impactor, 28mm |
00840286855211 | CS2 Acetabuler Screw Instruments Case 3 |
00840286855204 | CS2 Acetabular Trials Case 2 |
00840286855198 | CS2 Acetabular Reamer Case 1 |
00840286855822 | Ratchet Handle |
00840286855815 | Teflon Sleeve for Reamer |
00840286855808 | Drill, Bayonet, 3.2mm, 56mm |
00840286855792 | Drill, Bayonet, 3.2mm, 45mm |
00840286855785 | Drill, Bayonet, 3.2mm, 35mm |
00840286855778 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 68mm |
00840286855761 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 66mm |
00840286855754 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 64mm |
00840286855747 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 62mm |
00840286855730 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 60mm |
00840286855723 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 58mm |
00840286855716 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 56mm |
00840286855709 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 54mm |
00840286855693 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 52mm |
00840286855686 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 50mm |
00840286855679 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 48mm |
00840286855662 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 46mm |
00840286855655 | CS2, Trial, Acetabular Shell, Hemispherical, Holed, 44mm |
00840286855631 | Flexible Drilling Shaft, 60°, Assembly |
00840286855624 | UJ Screwdriver, Assembly, 3.5 Hex |
00840286855617 | Straight Hex Screwdriver |
00840286855600 | Screw Holding Forceps |
00840286855594 | Rigid Angled Depth Gauge |
00840286855570 | Reamer, Acetabular, 68mm |
00840286855563 | Reamer, Acetabular, 67mm |
00840286855556 | Reamer, Acetabular, 66mm |
00840286855549 | Reamer, Acetabular, 65mm |
00840286855532 | Reamer, Acetabular, 64mm |
00840286855525 | Reamer, Acetabular, 63mm |
00840286855518 | Reamer, Acetabular, 62mm |
00840286855501 | Reamer, Acetabular, 61mm |