FDA.report

Merocel

Primary DI
30886158012000
Brand
Merocel
Company
BEAVER-VISITEC INTERNATIONAL, INC.
Model
400108
Device description
Wick with 80cc Collection Bag
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HOZSponge, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOZSponge, OphthalmicOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30886158012000PrimaryGS10
00886158012009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615801200030886158012000
00886158012009008861580120098861580120090886158012009

GMDN Terms

TermDefinition
Surgical tissue/fluid collection bag, sterileA sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com

Regulatory Flags

DUNS number
001406024
Device count
20
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
true
Sterilization required before use
true

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
20385640090005WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090012WalcottSummit Medical, Inc.HOZ2026-02-03
40385640090016WalcottSummit Medical, Inc.HOZ2026-02-03
04260306710522Sugi sterile, sample, ophthalmologyQuestAlpha GmbH & Co. KGHOZ2025-08-15
00194613056841MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056872MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056896MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056919MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056926MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613100070MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118778MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118785MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118792MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118808MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118983MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118990MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119003MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119010MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119027MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056889MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-03-21
10194613018273MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613060746MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
04260306710478SugiQuestAlpha GmbH & Co. KGHOZ2024-07-31
04260306710164SugiQuestAlpha GmbH & Co. KGHOZ2024-07-08
30886158002384Visitec®Beaver-Visitec International, Inc.HOZ2024-06-27
30886158002391Visitec®Beaver-Visitec International, Inc.HOZ2024-06-27
30886158012055Ultracell®Beaver-Visitec International, Inc.HOZ2024-06-27
30886158012086Ultracell®Beaver-Visitec International, Inc.HOZ2024-06-27
30886158012147Ultracell®Beaver-Visitec International, Inc.HOZ2024-06-27
30886158012512StaarBeaver-Visitec International, Inc.HOZ2024-06-27