Vitale STRONG 20558

GUDID 00850005565819

Calcium Alginate Dressings with Antibacterial Silver, 4" x 8", 5/box, 10 boxes/case

CELLERA LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID00850005565819
NIH Device Record Key50260de1-6b35-4122-942a-9c3e54ec7b9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitale STRONG
Version Model Number20558
Catalog Number20558
Company DUNS960091929
Company NameCELLERA LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com
Phone800-892-2391
Emailsales@cellerallc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005565796 [Primary]
GS100850005565819 [Package]
Contains: 00850005565796
Package: box [5 Units]
In Commercial Distribution
GS110850005565816 [Package]
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-16

On-Brand Devices [Vitale STRONG]

00850005565505Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case
00850005565475Calcium Alginate Ropes, 5/box, 10 boxes/case
00850005565574Calcium Alginate Dressings, 4" x 8", 5/box, 10 boxes/case
00850005565550Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case
00850005565529Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
00850005565819Calcium Alginate Dressings with Antibacterial Silver, 4" x 8", 5/box, 10 boxes/case
00850005565789Calcium Alginate Dressings with Antibacterial Silver, 4" x 4", 10/box, 10 boxes/case
00850005565765Calcium Alginate Dressings with Antibacterial Silver, 4" x 5", 10/box, 10 boxes/case
00850005565741Calcium Alginate Dressings with Antibacterial Silver, 2" x 2", 10/box, 10 boxes/case
00850005565703Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case
00850031608153Calcium Alginate Dressings, 6" x 6", 1/pouch, 5/box, 10 boxes/case
00850031608160Calcium Alginate Dressings with Antibacterial Silver, 6" x 6", 1/pouch, 5/box, 10 boxes/case
00850031608542Silver Gelling Fiber Dressings 6"x6", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
00850031608528Gelling Fiber Dressing 6" x 6", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
00850031608504Silver Gelling Fiber Dressings 4"x8", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
00850031608481Silver Gelling Fiber Dressings 4"x5", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack
00850031608467Silver Gelling Fiber Dressings 4"x4", 1/pouch, 10/box, 10 boxes/case, 6 cases/overpack
00850031608443Silver Gelling Fiber Dressings 2"x2", 1/pouch, 10/box, 10 boxes/case, 8 cases/overpack
00850031608429Silver Gelling Fiber Ropes .8"x12", 1/pouch, 5/box, 10 boxes/case, 8 cases/overpack
00850031608405Gelling Fiber Dressing 4" x 8", 1/pouch, 5/box, 10 boxes/case, 4 cases/overpack
00850031608382Gelling Fiber Dressing 4" x 5", 1/pouch, 10/box, 10 boxes/case, 4 cases/overpack
00850031608368Gelling Fiber Dressing 4" x 4", 1/pouch, 10/box, 10 boxes/case, 6 cases/overpack
00850031608344Gelling Fiber Dressing 2" x 2", 1/pouch, 10/box, 10 boxes/case, 8 cases/overpack
00850031608320Gelling Fiber Rope .8" x 12", 1/pouch, 5/box, 10 boxes/case, 8 cases/overpack

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.