Comfort Plus Osteotome 7532-06

GUDID 00840199528707

Comfort Plus Osteotome 6mm Curved 16.5cm Handles 29cm Total Length

KOROS U.S.A., INC.

Orthopaedic osteotome
Primary Device ID00840199528707
NIH Device Record Key8702b3e7-fa7a-450e-b02c-bbd3c8eedfc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort Plus Osteotome
Version Model Number7532-06
Catalog Number7532-06
Company DUNS007928633
Company NameKOROS U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199528707 [Direct Marking]
GS110840199528704 [Primary]

FDA Product Code

KDGChisel (Osteotome)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


[00840199528707]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-08
Device Publish Date2024-12-31

On-Brand Devices [Comfort Plus Osteotome]

00840199528813Comfort Plus Osteotome 30mm Curved 20cm Handles 32cm Total Length
00840199528806Comfort Plus Osteotome 25mm Curved 20cm Handles 32cm Total Length
00840199528790Comfort Plus Osteotome 20mm Curved 20cm Handles 32cm Total Length
00840199528783Comfort Plus Osteotome 15mm Curved 20cm Handles 32cm Total Length
00840199528776Comfort Plus Osteotome 10mm Curved 20cm Handles 32cm Total Length
00840199528769Comfort Plus Osteotome 6mm Curved 20cm Handles 32cm Total Length
00840199528752Comfort Plus Osteotome 30mm Curved 16.5cm Handles 29cm Total Length
00840199528745Comfort Plus Osteotome 25mm Curved 16.5cm Handles 29cm Total Length
00840199528738Comfort Plus Osteotome 20mm Curved 16.5cm Handles 29cm Total Length
00840199528721Comfort Plus Osteotome 15mm Curved 16.5cm Handles 29cm Total Length
00840199528714Comfort Plus Osteotome 10mm Curved 16.5cm Handles 29cm Total Length
00840199528707Comfort Plus Osteotome 6mm Curved 16.5cm Handles 29cm Total Length
00840199528691Comfort Plus Osteotome 30mm Straight 20cm Handles 32cm Total Length
00840199528684Comfort Plus Osteotome 25mm Straight 20cm Handles 32cm Total Length
00840199528677Comfort Plus Osteotome 20mm Straight 20cm Handles 32cm Total Length
00840199528660Comfort Plus Osteotome 15mm Straight 20cm Handles 32cm Total Length
00840199528653Comfort Plus Osteotome 10mm Straight 20cm Handles 32cm Total Length
00840199528646Comfort Plus Osteotome 6mm Straight 20cm Handles 32cm Total Length
00840199528639Comfort Plus Osteotome 30mm Straight 16.5cm 29cm Total Length
00840199528622Comfort Plus Osteotome 25mm Straight 16.5cm 29cm Total Length
00840199528615Comfort Plus Osteotome 20mm Straight 16.5cm 29cm Total Length
00840199528592Comfort Plus Osteotome 15mm Straight 16.5cm Handles 29cm Total Length
00840199528578Comfort Plus Osteotome 10mm Straight 16.5cm Handles 29cm Total Length
00840199528561Comfort Plus Osteotome 6mm Straight 16.5cm Handles 29cm Total Length

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.