FDA UDI Not in Commercial Distribution 🇺🇸 United States

ClearCam Kelling

DI: B883SK300500110 · Model: 1 · Clearcam Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ClearCam Kelling
Primary DI
B883SK300500110
Version / Model
1
Catalog Number
SK3005001
Company Name
Clearcam Inc.
Labeler DUNS
081499310
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-01
Public Version
4
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
4a263812-c3af-48d1-8077-f129766e7275
Distribution End Date
2022-05-01

Device Description

Stryker Compatible 30cm X 05mm X 0 Degree Kelling device, Version 1

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
38835 Surgical instrument/endoscope cleaning utensil, single-use

Identifiers

Type ID
Primary B883SK300500110