FDA.reportPublic FDA data

Vitale

Primary DI
B492206442
Brand
Vitale
Company
CELLERA LLC
Model
20644
Catalog number
20644
Device description
Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
Published
2017-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing,Wound,Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B492206441PackageHIBCC10In Commercial Distribution
B492206442PackageHIBCC10In Commercial Distribution
B492206440PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, sterileA sterile wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-892-2391sales@cellerallc.com

Regulatory Flags#

DUNS number
960091929
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B492301500Glucertain30150301502017-06-07
00850065122090Vitale23077230772026-02-24
00850065122076Vitale 24408244082025-07-17
00850065122083Vitale 24408244082025-07-17
00850005565185Vitale22000220002019-05-24
00850005565376Vitale22011220112020-04-20
00850005565406Vitale22022220222020-04-20
00850005565420Vitale22044220442020-04-20
00850005565444Vitale22077220772020-04-20
00850031608559Vitale22088220882023-02-15
00850065122014Vitale22010220102025-04-11
00850005565901Vitale24203242032021-10-31
00850005565932Vitale24204242042021-11-02
00850005565956Vitale24206242062023-02-15
00850005565970Vitale24207242072023-02-15
00850031608054Vitale24209242092023-02-15
00850031608573Vitale 24406244062023-02-01
00850031608597Vitale 24410244102023-02-01
00850031608610Vitale 24414244142023-02-01
00850065122038Vitale24548245482025-04-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
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09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22