FDA UDI In Commercial Distribution 🇺🇸 United States

LENS

DI: 00885556618042 · Model: 72204894 · Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LENS
Primary DI
00885556618042
Version / Model
72204894
Catalog Number
72204894
Company Name
Smith & Nephew, Inc.
Labeler DUNS
045483575
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-12
Public Version
4
Public Version Date
2023-09-07
Public Version Status
Update
Public Device Record Key
d45b39d2-663a-4d62-90a9-847291f32872

Device Description

KIT GERMAN LENS INTEG SYSTEM NON-WIFI

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, general & plastic surgery

GMDN Terms

Code Name
35616 Endoscopic video imaging system

Identifiers

Type ID
Primary 00885556618042

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K153606 000