SHARD Premium+ IV Catheters

GUDID 10814639026242

SHARD Premium+ IV Catheters. 20Gx 1" with Flashback chamber. Radiopague. Pink. Sterile. Single Use.

APPLIED DENTAL, INC.

Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use Suction/irrigation tubing, single-use
Primary Device ID10814639026242
NIH Device Record Key24f766ce-df7c-403b-ac4c-084e804d24fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHARD Premium+ IV Catheters
Version Model NumberCAT-2025
Company DUNS017524666
Company NameAPPLIED DENTAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place. Avoid direct sun light.

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639026245 [Primary]
GS110814639026242 [Package]
Contains: 00814639026245
Package: box [50 Units]
In Commercial Distribution
GS120814639026249 [Package]
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-15
Device Publish Date2023-09-07

On-Brand Devices [SHARD Premium+ IV Catheters]

10814639026273SHARD Premium+ IV Catheters. 24Gx 0.75" with Flashback chamber. Radiopague. Yellow. Sterile. Si
10814639026266SHARD Premium+ IV Catheters. 22Gx 1" with Flashback chamber. Radiopague. Blue. Sterile. Single
10814639026259SHARD Premium+ IV Catheters. 20Gx 1.25" with Flashback chamber. Radiopague. Pink. Sterile. Sing
10814639026242SHARD Premium+ IV Catheters. 20Gx 1" with Flashback chamber. Radiopague. Pink. Sterile. Single
10814639026235SHARD Premium+ IV Catheters. 18Gx 1.25" with Flashback chamber. Radiopague. Green. Sterile. Sin
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.