Device
Instrument Stringer, Width 3 1/4", 7"
Manufacturer
ELMED INCORPORATED
Model: 13-0901 Catalog: 13-0901 DI: 00198506090400 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
Instrument Stringer, Width 3 1/4", 7"
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: 67bc5aca-08ea-4757-9b4d-1f278682531f
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: No
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: 00198506090400
Type: Primary
Issuing Agency: GS1
GMDN
Code: 44058
Name: General surgical procedure kit, non-medicated, reusable
Definition:
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.
FDA Product Codes
MDM
Instrument, Manual, Surgical, General Use