FDA.reportPublic FDA data

Ultracell®

Primary DI
30886158014783
Brand
Ultracell®
Company
Beaver-Visitec International, Inc.
Model
SM-NS30305-C
Catalog number
SM-NS30305-C
Device description
***NON-STERILE*** SHIPPERT MED FENESTRATED EAR WICK, 9MM DIA X 15MM (250/SP)
Published
2024-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCNEAR WICK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCNEar WickEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920357000ULTRACELL EAR WICKUltracell Medical Technologies, Inc.1993-02-01KCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158014783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088615801478330886158014783

GMDN Terms#

Term, Definition table
TermDefinition
Ear wick, non-biodegradableA non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27
30886158002650Visitec®5817085817082024-06-06
30886158010358Visitec000860100086012024-06-06
00886158002321Visiwipe5810475810472025-09-10
00886158106586BVIELP19CU5ELP19CU52025-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000888916MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
00763000888923MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
20763000888910MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
20763000888927MerocelMEDTRONIC XOMED, INC.KCN2026-02-15
08904428722648OSSEOUS PVA Eye SpearsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722655OSSEOUS PVA PointsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722662OSSEOUS PVA Corneal Light Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722679OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722686OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722693OSSEOUS PVA lASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722709OSSEOUS PVA LASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722716OSSEOUS PVA Eye Drain EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722723OSSEOUS PVA Eye Drain LargeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722730OSSEOUS PVA Eye WickEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722747OSSEOUS PVA Eye Wick and WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722754OSSEOUS PVA LASIK EYE EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722761OSSEOUS OSSEOUS PVA LASIK EYE Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722778OSSEOUS PVA LASIK EYEEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722785OSSEOUS PVA Instrument WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428722792OSSEOUS PVA Wick and WipeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746576OSSEOUS PVA Eye SpearsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746583OSSEOUS PVA PointsEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746590OSSEOUS PVA Corneal Light Shield EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746606OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746613OSSEOUS PVA Corneal Light ShieldEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746620OSSEOUS PVA lASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746637OSSEOUS PVA LASIK Eye DrainEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746644OSSEOUS PVA Eye Drain EON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746651OSSEOUS PVA Eye Drain LargeEON MEDITECH PRIVATE LIMITEDKCN2024-07-05
08904428746668OSSEOUS PVA Eye WickEON MEDITECH PRIVATE LIMITEDKCN2024-07-05