FDA.reportPublic FDA data

FUJIFILM

Primary DI
04547410524284
Brand
FUJIFILM
Company
FUJIFILM CORPORATION
Model
CB-01B
Device description
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410524284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410524284045474105242844547410524284

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope calibration cover, reusableA plastic cap/cover designed to be placed onto the distal end of an endoscope to allow white balance and/or 3-D adjustment to be calibrated in the electronic control unit of the endoscope. 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
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
713565195
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410582901FDR CROSS SlimDR-XD 3000 SLIM MBL E2026-08-14
04547410524642FUJIFILMEB-840T2026-07-30
04547410524680FUJIFILMEB-840S2026-07-30
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212325S3ESELS3ESEL2021-07-18
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

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