FDA UDI Not in Commercial Distribution 🇺🇸 United States

1077 EARTIP 12-16 BLUE 250 PCS

DI: 04260223141256 · Model: 8-68-32805 · PATH medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
250

Basic Information

Brand Name
1077 EARTIP 12-16 BLUE 250 PCS
Primary DI
04260223141256
Version / Model
8-68-32805
Company Name
PATH medical GmbH
Labeler DUNS
551540334
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
250
Record Status
Published
Publish Date
2016-06-29
Public Version
4
Public Version Date
2020-06-24
Public Version Status
Update
Public Device Record Key
4b788aeb-bb2f-4482-86a8-817f8e5ed3ec
Distribution End Date
2020-06-23

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
Primary 04260223141256
Unit of Use 04260223140600