FDA UDI In Commercial Distribution 🇺🇸 United States

Flex Lap™

DI: 00848657010344 · Model: FL1380 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Flex Lap™
Primary DI
00848657010344
Version / Model
FL1380
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
2016-12-07
Public Version
4
Public Version Date
2019-08-21
Public Version Status
Update
Public Device Record Key
4ffa895d-b011-42cf-83d6-11cfb2eacdf9

Device Description

Retraction Jaw, Double Action, 5mm

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
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
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
35080 Rigid endoscopic tissue manipulation forceps, reusable

Identifiers

Type ID
Primary 00848657010344