Device
SOFT TISSUE POWER ELEVATOR: 3MM X 26CM STRAIGHT W/ XMAS TREE ADAPTER
Manufacturer
BLACK & BLACK SURGICAL, INC.
BLACK & BLACK SURGICAL, INC.
Model: B8BX-STE-326 PWRX
Catalog: B8BX-STE-326 PWRX
DI: 00840329837716
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
SOFT TISSUE POWER ELEVATOR: 3MM X 26CM STRAIGHT W/ XMAS TREE ADAPTER
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:
018f827f-faa1-49e3-80a4-88e32013cc93
Distribution Status:
In Commercial Distribution
DUNS Number:
004382282
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:
Yes
Identifiers
Device ID:
00840329837716
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35047
Name: ENT elevator
Definition:
A hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.
FDA Product Codes
GEG
ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY