FDA UDI In Commercial Distribution 🇺🇸 United States

ELAN 4

DI: 04046963794255 · Model: GA800 · Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ELAN 4
Primary DI
04046963794255
Version / Model
GA800
Catalog Number
GA800
Company Name
Aesculap AG
Labeler DUNS
315018218
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-25
Public Version
5
Public Version Date
2023-07-14
Public Version Status
Update
Public Device Record Key
83f2f27e-a042-45ab-9af0-4233a2eb09cd

Device Description

ELAN 4 ELECTRO CONTROL UNIT

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
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

GMDN Terms

Code Name
41264 Surgical power tool system control unit, line-powered

Identifiers

Type ID
Primary 04046963794255

Customer Contacts