Model: 1
DI: B35675400020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Sterilization
Method Types - Sterilization Method:
Microwave Radiation
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c6ceeed6-e4d9-4524-8cc7-d8b7fc42af95
Distribution Status:
In Commercial Distribution
DUNS Number:
109909627
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B35675400020
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 62558
Name: General-purpose curette
Definition:
A hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.
FDA Product Codes
GAC
Rasp, Surgical, General & Plastic Surgery