FDA UDI In Commercial Distribution 🇺🇸 United States

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO

DI: M648C0100120 · Model: C010012 · OBP CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO
Primary DI
M648C0100120
Version / Model
C010012
Company Name
OBP CORPORATION
Labeler DUNS
011560431
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-11
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
fbc70530-cc47-4b13-bf38-b5a3a822fd9d

Device Description

C010012 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO (Customer REF 27550ZAG/10)

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HET Laparoscope, Gynecologic (And Accessories)
HIH Hysteroscope (And Accessories)
ODC Endoscope Channel Accessory

GMDN Terms

Code Name
60650 Endoscope working-channel seal

Identifiers

Type ID
Package M648C0100121
Primary M648C0100120