FDA UDI In Commercial Distribution 🇺🇸 United States

ASSI

DI: 00841645100508 · Model: 121020BP · ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ASSI
Primary DI
00841645100508
Version / Model
121020BP
Company Name
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Labeler DUNS
055870299
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-25
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
5b43c417-da46-4aaf-a5ab-0f27ee291681

Device Description

Small Bayonet Micro BP Fcps., W /Suction 18.5cm,Tip 1.0mm Dia.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
47848 Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Identifiers

Type ID
Primary 00841645100508

Premarket Submissions

Submission Number Supplement Number
K811820 000