Comfort Plus Chisel 7540-15

GUDID 00840199528851

Comfort Plus Chisel 15mm Straight 16.5cm Handles 29cm Total Length

KOROS U.S.A., INC.

Orthopaedic chisel
Primary Device ID00840199528851
NIH Device Record Key79d8cef9-be50-4876-b1f0-ae1d55c0e75f
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort Plus Chisel
Version Model Number7540-15
Catalog Number7540-15
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
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
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
GS100840199528851 [Direct Marking]
GS110840199528858 [Primary]

FDA Product Code

KDGChisel (Osteotome)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

[00840199528851]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-08
Device Publish Date2024-01-31

On-Brand Devices [Comfort Plus Chisel]

00840199529063Comfort Plus Chisel 30mm Tip 20cm Handles 32cm Total Length
00840199529056Comfort Plus Chisel 25mm Tip 20cm Handles 32cm Total Length
00840199529049Comfort Plus Chisel 20mm Tip 20cm Handles 32cm Total Length
00840199529032Comfort Plus Chisel 15mm Tip 20cm Handles 32cm Total Length
00840199529025Comfort Plus Chisel 10mm Tip 20cm Handles 32cm Total Length
00840199529018Comfort Plus Chisel 6mm Tip 20cm Handles 32cm Total Length
00840199529001Comfort Plus Chisel 30mm Curved 16.5cm Handles 29cm Total Length
00840199528998Comfort Plus Chisel 25mm Curved 16.5cm Handles 29cm Total Length
00840199528981Comfort Plus Chisel 20mm Curved 16.5cm Handles 29cm Total Length
00840199528974Comfort Plus Chisel 15mm Curved 16.5cm Handles 29cm Total Length
00840199528967Comfort Plus Chisel 10mm Curved 16.5cm Handles 29cm Total Length
00840199528950Comfort Plus Chisel 6mm Curved 16.5cm Handles 29cm Total Length
00840199528943Comfort Plus Chisel 30mm Straight 20cm Handles 32cm Total Length
00840199528936Comfort Plus Chisel 25mm Straight 20cm Handles 32cm Total Length
00840199528929Comfort Plus Chisel 20mm Straight 20cm Handles 32cm Total Length
00840199528912Comfort Plus Chisel 15mm Straight 20cm Handles 32cm Total Length
00840199528905Comfort Plus Chisel 10mm Straight 20cm Handles 32cm Total Length
00840199528899Comfort Plus Chisel 6mm Straight 20cm Handles 32cm Total Length
00840199528882Comfort Plus Chisel 30mm Straight 16.5cm Handles 29cm Total Length
10840199528872Comfort Plus Chisel 25mm Straight 16.5cm Handles 29cm Total Length
00840199528868Comfort Plus Chisel 20mm Straight 16.5cm Handles 29cm Total Length
00840199528851Comfort Plus Chisel 15mm Straight 16.5cm Handles 29cm Total Length
00840199528844Comfort Plus Chisel 10mm Straight 16.5cm Handles 29cm Total Length
00840199528837Comfort Plus Chisel 6m Straight 16.5cm 29cm Total Length
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.