FDA UDI Not in Commercial Distribution 🇺🇸 United States

BIPOLAR IRIS FORCEPS

DI: B09927009350 · Model: 2700-935 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BIPOLAR IRIS FORCEPS
Primary DI
B09927009350
Version / Model
2700-935
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-14
Public Version
5
Public Version Date
2018-09-24
Public Version Status
Update
Public Device Record Key
8bc49d90-3bd2-4de9-a2ff-db63a07b36f7
Distribution End Date
2018-09-22

Device Description

BIPOLAR IRIS FORCEPS STRAIGHT

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
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", "Dry Heat Sterilization"]

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
32684 Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Identifiers

Type ID
Primary B09927009350

Customer Contacts

Phone
800-821-7496

Device Sizes

Type Value Unit Text
Device Size Text, specify .4mm Jaw
Length 3.25 Inch