FDA UDI Not in Commercial Distribution 🇺🇸 United States

AED

DI: 00848657010139 · Model: SDLP1130 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AED
Primary DI
00848657010139
Version / Model
SDLP1130
Company Name
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Labeler DUNS
839138955
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-22
Public Version
9
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
e4f25999-e027-4f5b-b404-18d2092b49e4
Distribution End Date
2018-12-18

Device Description

Extra-Long Lap Tray. Lightweight polymer. Manufactured from medical grade polymer Radel-R©. Length 25.5" x Width 12" x Height 5.5"

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
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00848657010139