Device
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Manufacturer
SIGNUS Medizintechnik GmbH
SIGNUS Medizintechnik GmbH
Model: Threaded awl cannulated, obturator
Catalog: AC0088
DI: 04047844129241
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
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:
c0333b17-8553-47f6-abfc-e9a12f74ecea
Distribution Status:
In Commercial Distribution
DUNS Number:
344203948
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04047844129241
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44054
Name: Orthopaedic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument
Device Sizes
Device Size - Size Text:
Ø8,5mm
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
0
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
35
Storage Handling - Storage Handling Type:
Storage Environment Temperature