FDA UDI In Commercial Distribution 🇺🇸 United States

ELMED

DI: 00842180165908 · Model: 23-1790-03 · ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ELMED
Primary DI
00842180165908
Version / Model
23-1790-03
Catalog Number
23-1790-03
Company Name
ELMED INCORPORATED
Labeler DUNS
049290364
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-23
Public Version
1
Public Version Date
2023-03-31
Public Version Status
New
Public Device Record Key
2798b3b5-e10a-4804-a10c-840200827af0

Device Description

Intraarticular Tissue Grasper / Rongeur, 7”Standard, 10” Overall Length, 7” Shaft Length, Surgical Grade Stainless Steel (No Ridges on Top Slide)

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
33442 Craniofacial rongeur, reusable

Identifiers

Type ID
Primary 00842180165908

Customer Contacts

Phone
224-353-6446