FDA UDI In Commercial Distribution 🇺🇸 United States

Single-Site

DI: 00886874112045 · Model: 428074 · INTUITIVE SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Single-Site
Primary DI
00886874112045
Version / Model
428074
Company Name
INTUITIVE SURGICAL, INC.
Labeler DUNS
938647021
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-08
Public Version
8
Public Version Date
2021-02-22
Public Version Status
Update
Public Device Record Key
42e1bae0-3a02-44cb-a9f0-f0e0ab140bf8

Device Description

FLEXIBLE BLUNT OBTRUATOR

Device Characteristics

Single Use
No
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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NAY System,surgical,computer controlled instrument
GCJ Laparoscope, general & plastic surgery

GMDN Terms

Code Name
35692 Rigid endoscope obturator

Identifiers

Type ID
Primary 00886874112045

Device Sizes

Type Value Unit Text
Length 250 Millimeter
Outer Diameter 5 Millimeter