FDA UDI In Commercial Distribution 🇺🇸 United States

AED

DI: 00848657085175 · Model: A1318 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
AED
Primary DI
00848657085175
Version / Model
A1318
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
2019-05-07
Public Version
2
Public Version Date
2019-08-21
Public Version Status
Update
Public Device Record Key
c5916d68-12d2-4369-84e8-b7e2dea6463c

Device Description

AED 5MM X 33CM MARYLAND GRASPER, ROTATING W/ LEUR PORT

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
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
No

Product Codes

Code Name
GEI Electrosurgical, cutting & coagulation & accessories

GMDN Terms

Code Name
35080 Rigid endoscopic tissue manipulation forceps, reusable

Identifiers

Type ID
Primary 00848657085175