FDA UDI Not in Commercial Distribution 🇺🇸 United States

FORCEPS CORD

DI: 00192896009233 · Model: A827F · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FORCEPS CORD
Primary DI
00192896009233
Version / Model
A827F
Catalog Number
A827F
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-15
Public Version
2
Public Version Date
2020-10-19
Public Version Status
Update
Public Device Record Key
9bd9b518-1273-4dde-9ca0-ac9b79e4057b
Distribution End Date
2020-10-16

Device Description

FORCEPS CORD

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
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 00192896009233

Customer Contacts

Phone
800-821-7496

Premarket Submissions

Submission Number Supplement Number
K001955 000