Primary Device ID | 00840199527724 |
NIH Device Record Key | f9a5a459-7ad1-45b6-8478-2800f3842491 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Osteotome |
Version Model Number | 7452-62 |
Catalog Number | 7452-62 |
Company DUNS | 007928633 |
Company Name | KOROS U.S.A., 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 | true |
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 | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.com | |
Phone | 1-805-529-0825 |
customerservice@korosUSA.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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840199527724 [Direct Marking] |
GS1 | 10840199527721 [Primary] |
KDG | Chisel (Osteotome) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
[00840199527724]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-08 |
Device Publish Date | 2024-01-31 |
00840199527854 | Koros-Scaglietti Long Osteotome 19mm Curved 28cm 11" Length |
00840199527847 | Koros-Scaglietti Long Osteotome 16mm Curved 28cm 11" Length |
00840199527830 | Koros-Scaglietti Long Osteotome 12mm Curved 28cm 11" Length |
10840199527820 | Koros-Scaglietti Long Osteotome 9mm Curved 28cm 11" Length |
00840199527816 | Koros-Scaglietti Long Osteotome 6mm Curved 28cm 11" Length |
00840199527809 | Koros-Scaglietti Osteotome 19mm Curved 22cm 8-1/2" Length |
00840199527793 | Koros-Scaglietti Osteotome 16mm Curved 22cm 8-1/2" Length |
00840199527786 | Koros-Scaglietti Osteotome 12mm Curved 22cm 8-1/2" Length |
00840199527779 | Koros-Scaglietti Osteotome 9mm Curved 22cm 8-1/2" Length |
00840199527762 | Koros-Scaglietti Osteotome 6mm Curved 22cm 8-1/2" Length |
00840199527748 | Anterior Osteotomes 19mm Straight 43cm 17" Length |
00840199527731 | Anterior Osteotome 16mm Straight 43cm 17" Length |
00840199527724 | Anterior Osteotome 12mm Straight 43cm 17" Length |
10840199527714 | Anterior Osteotomes 9mm Straight 43cm 17" Length |
00840199527700 | Anterior Osteotomes 6mm Straight 43cm 17" Length |
00840199527670 | Koros-Scaglietti Long Osteotome 19mm Straight 28cm 11" Length |
00840199527663 | Koros-Scaglietti Long Osteotome 16mm Straight 28cm 11" Length |
00840199527656 | Koros-Scaglietti Long Osteotome 12mm Straight 28cm 11" Length |
00840199527649 | Koros-Scaglietti Long Osteotome 9mm Straight 28cm 11" Length |
00840199523450 | Spinal Delicate Osteotome Curved 10mm, 32cm Length |
00840199523443 | Spinal Delicate Osteotome Straight Tip 10mm, 32cm Length |
00840199522989 | Lateral Osteotome Straight Tip with Microscope Handle 10mm, 7-1/2" Shaft 19cm, 5-1/2" 14cm Handl |
00840199522286 | Lateral Osteotome Straight Tip with Microscope Handle, 10mm, 7-1/2" Shaft 19cm, 5-1/2" 14cm Hand |
00840199522279 | Lateral Osteotome Straight Tip with Offset Handle, 10mm, 8-1/2" Shaft 21.5cm, 9-3/4" 25cm Handle |
00840199522262 | Lateral Osteotome Straight Tip with Straight Handle, 10mm, 8-1/2" Shaft 21.5cm, 9-1/2" 24cm Hand |
00840199527632 | Scaglietti Long Osteotome 6mm Straight 11"/28cm |
00840199527601 | Koros-Scaglietti Osteotome 19mm Straight 22cm 8-1/2" Length |
00840199527595 | Koros-Scaglietti Osteotome 16mm Straight 22cm 8-1/2" Length |
00840199527588 | Koros-Scaglietti Osteotome 12mm Straight 22cm 8-1/2" Length |
00840199527571 | Koros-Scaglietti Osteotome 9mm Straight 22cm 8-1/2" Length |
00840199527564 | Koros-Scaglietti Osteotome 6mm Straight 22cm 8-1/2" Length |
00840199527489 | Coughlin Osteotome Curved 12mm Tip, 19.5cm Length |
00840199527472 | Coughlin Osteotome Curved 10mm Tip, 19.5cm Length |
00840199527465 | Coughlin Osteotome Curved 8mm Tip, 19.5cm Length |
00840199527458 | Coughlin Osteotome Curved 6mm Tip, 19.5cm Length |
00840199527441 | Coughlin Osteotome Curved 4mm Tip, 19.5cm Length |
00840199527434 | Coughlin Osteotome Straight 12mm Tip, 19.5cm Length |
00840199527427 | Coughlin Osteotome Straight 10mm Tip, 19.5c Length |
00840199527410 | Coughlin Osteotome Straight 8mm Tip, 19.5cm Length |
00840199527403 | Coughlin Osteotome Straight 6mm Tip, 19.5cm Length |
00840199527397 | Coughlin Osteotome Straight 4mm Tip, 19.5cm Length |