FDA.report

Zenflow Spring® Implant Retrieval Device

Primary DI
00850081334040
Brand
Zenflow Spring® Implant Retrieval Device
Company
ZENFLOW, INC.
Model
ZFS-IRD-01
Catalog number
ZFS-IRD-01
Published
2026-05-22
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

Contact Domains

Product Codes

CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850081334040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850081334040008500813340408500813340400850081334040

GMDN Terms

TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Contacts

PhoneEmail
650-419-7557info@zenflow.com

Regulatory Flags

DUNS number
079412969
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
false
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 DIBrandModelCatalogPublished
00850081334002Zenflow Spring® Implant and Delivery SystemZFS-IMP-15-01ZFS-IMP-15-012026-05-22
00850081334019Zenflow Spring® Implant and Delivery SystemZFS-IMP-18-01ZFS-IMP-18-012026-05-22
00850081334026Zenflow Spring® Implant and Delivery SystemZFS-IMP-21-01ZFS-IMP-21-012026-05-22
00850081334033Zenflow Spring® ScopeZFS-SCP-01ZFS-SCP-012026-05-22
00850081334057Zenflow Camera Control UnitZFS-CCU-01ZFS-CCU-012026-05-22

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