FDA UDI In Commercial Distribution 🇺🇸 United States

AED

DI: 00848657009638 · Model: LB1671 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AED
Primary DI
00848657009638
Version / Model
LB1671
Company Name
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Labeler DUNS
839138955
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-10
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
331d3bc1-cf86-4c4c-8649-f473515f3c85

Device Description

Retractor Band Applier, 5mm, 38cm, 90' Deflecting Tip, Axial Ring Handle, Articulating ESO Dissector

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
Yes
Has Serial Number
Yes
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
NWV Laparoscopic accessories, gynecologic

GMDN Terms

Code Name
45918 Hand-held surgical retractor, reusable

Identifiers

Type ID
Primary 00848657009638