FDA.reportPublic FDA data

SUCTION CYLINDER PROTECTOR

Primary DI
04953170200762
Brand
SUCTION CYLINDER PROTECTOR
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1453
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFYAdaptor, bulbs, miscellaneous, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170200762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170200762049531702007624953170200762

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cleaning brush, reusableA device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
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
04953170421594HD CAMERA HEADCH-S200-08-LBN61317402026-07-22
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995356699CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356705CLEANASCOPECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356712CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
00724995356729CLEANASCOPE ADVANTAGECANTEL MEDICAL (ITALY) SRLFFY2026-05-26
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedFFY2026-03-13
04897106957743andorate® Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-11-21
04547410564112FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
14547410564119FUJIFILMFUJIFILM CORPORATIONFFY2025-10-24
04897106957804Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957811Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957828Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957798Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957801Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957818Biopsy Port Cleaning AdapterGA Health Company LimitedFFY2025-08-04
14897106957825Air/Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-08-04
04897106957071Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
14897106957078Air Water Channel Cleaning AdapterGA Health Company LimitedFFY2025-07-31
00850025860857CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRMicro-tech UsaFFY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100Micro-tech UsaFFY2025-05-12
06009900408316PeditrolWISMED PL SP Z O OFFY2025-03-17
16009900408313PeditrolWISMED PL SP Z O OFFY2025-03-17
06009900408330Smart BulbWISMED PL SP Z O OFFY2025-03-17
06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17