FDA UDI In Commercial Distribution 🇺🇸 United States

1077 EARTIP 12-16 BLUE 100 PCS

DI: 04260223145346 · Model: 8-68-34507 · PATH medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
1077 EARTIP 12-16 BLUE 100 PCS
Primary DI
04260223145346
Version / Model
8-68-34507
Company Name
PATH medical GmbH
Labeler DUNS
551540334
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-06-27
Public Version
1
Public Version Date
2020-07-06
Public Version Status
New
Public Device Record Key
4bb5ab9a-311c-4d19-b0e0-4fbb1a102082

Device Characteristics

Single Use
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GWJ Stimulator, Auditory, Evoked Response
ETT Cushion, Earphone (For Audiometric Testing)

GMDN Terms

Code Name
35747 Evoked-potential audiometer

Identifiers

Type ID
Unit of Use 04260223140600
Primary 04260223145346