Disposable Distal End Tape Hood

Primary DI
06973786293321
Brand
Disposable Distal End Tape Hood
Company
Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)
Model
WDA-160-20-03B
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252457000Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.2026-01-30FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973786292727PackageGS150In Commercial Distribution
16973786296756PackageGS1100In Commercial Distribution
06973786293321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697378629272716973786292727
1697378629675616973786296756
06973786293321069737862933216973786293321

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope patient protection cap, single-useAn invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.

Regulatory Flags#

DUNS number
778435473
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06973786291563Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
06973786291570Flexible Video-CholedochoscopeCHV-US120J-U2025-03-19
06973786290337Disposable Endoscope Valves KitSG-DVK-OL-2002024-10-25
06973786290344Disposable Endoscope Valves KitSG-DVK-OL-200E2024-10-25
06973786290368Disposable Endoscope Valves KitSG-DVK-FJ-7002024-10-25
06973786290375Disposable Endoscope Valves KitSG-DVK-FJ-700E2024-10-25
06973786290399Disposable Endoscope Valves KitSG-DVK-PT-I10902024-10-25
06973786290405Disposable Endoscope Valves KitSG-DVK-PT-I1090E2024-10-25
06973786290139lmaging Processor System (lncluding Light Source)PL-21002023-07-26
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(STD)2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(STD)2024-09-14
06973786290078lmaging Processor System (lncluding Light Source)PL-10002023-07-26
06973786290559Flexible Video-Choledo-Cysto-UreteroscopeCHV-100-E2023-07-26
06973786290566Flexible Video-Choledo-Cysto-UreteroscopeCHV-100T-E2023-07-26
06973786290573Flexible Video-Choledo-Cysto-UreteroscopeCHV-US100-H2023-07-26
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeUV-100-E2023-07-26
06973786290597Flexible Video-Choledo-Cysto-UreteroscopeUV-110-E2023-07-26
06973786290603Flexible Video-Choledo-Cysto-UreteroscopeUV-100T-E2023-07-26
06973786290610Flexible Video-Choledo-Cysto-UreteroscopeUV-110T-E2023-07-26
06973786290627Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(REV)2023-07-26

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