FDA UDI Not in Commercial Distribution 🇺🇸 United States

E-LINE

DI: 04055207045558 · Model: 86520347 · Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
E-LINE
Primary DI
04055207045558
Version / Model
86520347
Catalog Number
8652.0347
Company Name
Richard Wolf GmbH
Labeler DUNS
315304071
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-26
Public Version
6
Public Version Date
2023-05-29
Public Version Status
Update
Public Device Record Key
6a21fc9d-160b-407f-94fe-b3c3a3712c73
Distribution End Date
2018-08-01

Device Description

OBTURATOR FOR CYSTOSCOPE 19.5FR color code red, WL 230mm, oval, rounded distal end, compatible with sheath 86520345, reusable

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
FBO CYSTOURETHROSCOPE

GMDN Terms

Code Name
35692 Rigid endoscope obturator

Identifiers

Type ID
Primary 04055207045558

Customer Contacts

Phone
+497043350

Device Sizes

Type Value Unit Text
Outer Diameter 6.5 Millimeter