Device
Valve Leaflet Retractor 11mm Blade, 260mm Overall Length, Angles Distal Tip Surgical Grade Stainless Steel
Manufacturer
Avalign Technologies, Inc.
Model: 72-150925MK DI: 00190776420901 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Valve Leaflet Retractor 11mm Blade, 260mm Overall Length, Angles Distal Tip Surgical Grade Stainless Steel
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: 0cda363b-78a6-4807-af94-39e6b70f223a
Distribution Status: In Commercial Distribution
DUNS Number: 792528510
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: 00190776420901
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45918
Name: Hand-held surgical retractor, reusable
Definition:
A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
FDA Product Codes
DWS
Instruments, Surgical, Cardiovascular