Device
FEMORAL TIBIAL SPREADER, SMALL W/ GROOVED PADS, OVER ALL LENGTH 7", PADS : 23 X 12MM, OPENS TO 39MM, INSULATED PADS
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 23-1850-01
Catalog: 23-1850-01
DI: 00198506090363
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
FEMORAL TIBIAL SPREADER, SMALL W/ GROOVED PADS, OVER ALL LENGTH 7", PADS : 23 X 12MM, OPENS TO 39MM, INSULATED PADS
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:
b6472742-3ac9-434f-bed8-ca4f5433132a
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
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:
00198506090363
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44091
Name: Arthroscopic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
FDA Product Codes
NBH
Accessories, Arthroscopic