SurePass CTR NS Blade

GUDID 00860011634836

Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade

Dev4

Manual scalpel blade, reusable
Primary Device ID00860011634836
NIH Device Record Key16d31d1e-d758-4e41-b920-dab24c0e4c9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurePass CTR NS Blade
Version Model NumberCT-2003NS
Company DUNS119211016
Company NameDev4
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 Numberfalse
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

Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com
Phone832-257-0845
Emailjeff@dev-4.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011634836 [Primary]
GS110860011634833 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


[00860011634836]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

Devices Manufactured by Dev4

00860011634829 - SurePass CTR NS Guide2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide
00860011634836 - SurePass CTR NS Blade2025-05-28Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
00860011634836 - SurePass CTR NS Blade2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade

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