Device
SOFT TISSUE POWER ELEVATOR: 3MM X 26CM STRAIGHT W/ XMAS TREE ADAPTER
Manufacturer
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