FDA.reportPublic FDA data

Vitale

Primary DI
00850065122045
Brand
Vitale
Company
CELLERA LLC
Model
24548
Catalog number
24548
Device description
Vitale Cover Dressings, 4" x 8", 30/box, 10 boxes/case
Published
2025-04-16
Public version status
New
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
00850065122045PackageGS130In Commercial Distribution
10850065122042PackageGS110In Commercial Distribution
00850065122038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065122045008500651220458500651220450850065122045
1085006512204210850065122042
00850065122038008500651220388500651220380850065122038

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan 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
00850031608146Vitale STRONG20656206562023-02-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04
00197998326615Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998326653Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367281Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367359Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998367427Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
00197998152252Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152344Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152375Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305801Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305832Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305863Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305894Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305924Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305955Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415500Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415548Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415586Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415623Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998418976Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419010Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419058Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419829Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
06948909462250GentellShaoxing Haoshide Medical Products Co., Ltd.NAC2026-08-21
06940610127725VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127787VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127848VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14