FDA.reportPublic FDA data

Ultracell®

Primary DI
30886158012222
Brand
Ultracell®
Company
Beaver-Visitec International, Inc.
Model
NS10110-CTN
Catalog number
NS10110-CTN
Device description
***NON-STERILE*** CLASSIC NASAL PACK W/TUBE, 8 CM W/STRING, NO VAC FOIL (500/SP)
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMXBALLOON, EPISTAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158012222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088615801222230886158012222

GMDN Terms#

Term, Definition table
TermDefinition
ENT space-occupying dressing, human-derivedA sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery. It is typically available as gel or gelatin sponge of human tissue origin. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00886158106609BVIOME6000UOME6000U2025-08-11
00886158034247BVIFS6000FS60002025-07-22
00886158034674BVIELP19SU1ELP19SU12025-07-22
00886158034681BVIELP19CU1ELP19CU12025-07-22
00886158037569BVIFS6001FS60012025-07-22
00886158037576BVIOME6001UOME60012025-07-22
30886158032121CustomEyes®58001721580017212024-07-01
30886158032428CustomEyes®58001713580017132024-07-01
30886158032435CustomEyes®58001764580017642024-07-01
30886158032442CustomEyes®58001711580017112024-07-01
30886158032473CustomEyes®58001706580017062024-07-01
30886158032480CustomEyes®58001737580017372024-07-01
30886158032497CustomEyes®58001753580017532024-07-01
30886158032787CustomEyes®58001809580018092024-07-01
30886158032800CustomEyes®58001775580017752024-07-01
30886158032886CustomEyes®58001774580017742024-07-01
30886158032893CustomEyes®58001825580018252024-07-01
30886158032985CustomEyes®58001836580018362024-07-01
30886158033166CustomEyes®58001865580018652024-07-01
30886158033180CustomEyes®58001818580018182024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10855364004112Rhino-Pak 45mmMAR-MED INC.EMX2025-02-06
00855364004122Rhino-Pak 55mmMAR-MED INC.EMX2025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.EMX2025-02-06
00821925030831Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925022379Gyrus ACMIGyrus Acmi, Inc.EMX2024-07-25
30886158012239Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012246Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012253Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012260Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012284Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012291Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012314Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012321Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012338Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012345Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012352Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012369Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012376Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012383Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012390Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012406Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012437Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012444Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012451Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013243Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013267Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013274Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013281Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013298Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013304Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27