Model: YZM100365
DI: 00810136259834
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Paddle Distractor 5
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:
ea46ae89-948f-4503-bc0b-ddcbc482b1eb
Distribution Status:
In Commercial Distribution
DUNS Number:
105224126
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:
00810136259834
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56637
Name: Orthopaedic surgical distractor, internal
Definition:
A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
5
Device Size - Size Type:
Height