FDA.reportPublic FDA data

Vitale

Primary DI
00850031608726
Brand
Vitale
Company
CELLERA LLC
Model
25244
Catalog number
25244
Device description
"Silicone Super-Absorbent Dressing, Non-Bordered 4"" x 4"", 1/pouch, 10/box, 10 boxes/case, 2 cases/overpack"
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850031608733PackageGS110In Commercial Distribution
10850031608730PackageGS110In Commercial Distribution
20850031608737PackageGS12In Commercial Distribution
00850031608726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850031608733008500316087338500316087330850031608733
1085003160873010850031608730
2085003160873720850031608737
00850031608726008500316087268500316087260850031608726

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
960091929
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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