Model: NPBOWL
Catalog: NPBOWL
DI: G149NPBOWL0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Mixing Bowl with Non-Slip Cover
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:
6dfecd00-d44c-4c4b-a5f3-2621e6c0797a
Distribution Status:
In Commercial Distribution
DUNS Number:
645459892
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G149NPBOWL0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 45253
Name: Orthopaedic cement preparation/delivery kit
Definition:
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
FDA Product Codes
FSM
Tray, Surgical, Instrument