FDA.report

SEPLOU

Primary DI
06976358503859
Brand
SEPLOU
Company
SEPLOU (ZHUHAI) CO.,LTD.
Model
SPAS1350S
Device description
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Published
2025-09-17
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

Related Records

Product Codes

CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976358503859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976358503859069763585038596976358503859

GMDN Terms

TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
847378548
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06976358502135SEPLOUURS30162025-09-17
06976358502142SEPLOUURS3016E2025-09-17
06976358502159SEPLOUURS30062025-09-17
06976358502166SEPLOUURS3006E2025-09-17
06976358502173SEPLOUURS30052025-09-17
06976358502180SEPLOUURS3005E2025-09-17
06976358503668SEPLOUSPAS10282025-09-17
06976358503675SEPLOUSPAS10352025-09-17
06976358503682SEPLOUSPAS10452025-09-17
06976358503699SEPLOUSPAS11352025-09-17
06976358503705SEPLOUSPAS11452025-09-17
06976358503712SEPLOUSPAS12352025-09-17
06976358503729SEPLOUSPAS12452025-09-17
06976358503736SEPLOUSPAS13352025-09-17
06976358503743SEPLOUSPAS13452025-09-17
06976358503750SEPLOUSPAS14352025-09-17
06976358503767SEPLOUSPAS14452025-09-17
06976358503774SEPLOUSPAS1033S2025-09-17
06976358503781SEPLOUSPAS1040S2025-09-17
06976358503798SEPLOUSPAS1050S2025-09-17

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