FDA.reportPublic FDA data

FUJIFILM

Primary DI
34547410079129
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
WB11002FW2
Device description
This product is intended to clean the instrument/suction channel and accessories during pre-cleaning of a FUJIFILM endoscope.
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34547410079129PackageGS11In Commercial Distribution
44547410079126PackageGS11In Commercial Distribution
04547410079128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454741007912934547410079129
4454741007912644547410079126
04547410079128045474100791284547410079128

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00There must be no condensation.
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596201367OASISMR-NVC-120OASIS RAPID NV Coil MR-NVC-1202026-05-29
04573596201398OASISMR-QFC-120OASIS QD Flexible Body Coil(L) MR-QFC-1202026-05-29
04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
04573596202159OASISMR-IBC-120OASIS RAPID Breast Coil MR-IBC-1202026-05-29
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
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10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
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