Device
ANC218
Manufacturer
NEWCLIP TECHNICS
Model: ANC218 Catalog: ANC218 DI: 03700569620479 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: b59b7453-952e-420e-9cc2-d3aab25b30dc
Distribution Status: In Commercial Distribution
DUNS Number: 263281904
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: 03700569620479
Type: Primary
Issuing Agency: GS1
GMDN
Code: 44795
Name: Manual orthopaedic bender, reusable
Definition:
A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.
FDA Product Codes
HXP
Instrument, Bending Or Contouring