Device
Biopsy Forceps are designed specifically to collect tissue endoscopically for histologic examinations.
Manufacturer
SEPLOU (ZHUHAI) CO.,LTD.
SEPLOU (ZHUHAI) CO.,LTD.
Model: SPBF18061
DI: 06976358503958
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Biopsy Forceps are designed specifically to collect tissue endoscopically for histologic examinations.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0d640962-e521-4d3a-8d0d-77eb9a903a63
Distribution Status:
In Commercial Distribution
DUNS Number:
847378548
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06976358503958
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33199
Name: Flexible endoscopic tissue manipulation forceps, single-use
Definition:
A 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.
FDA Product Codes
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt