FDA UDI Not in Commercial Distribution 🇺🇸 United States

COOLEY BULLDOG CLAMP

DI: B09921004270 · Model: 2100-427 · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
COOLEY BULLDOG CLAMP
Primary DI
B09921004270
Version / Model
2100-427
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-19
Public Version
11
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
fffb9d0d-9fc5-4856-b9b5-63772ec6fe28
Distribution End Date
2018-09-23

Device Description

COOLEY BULLDOG CLAMP CROSS ACTION CURVED

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
["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
DXC Clamp, Vascular

GMDN Terms

Code Name
62470 Surgical bulldog clamp, reusable

Identifiers

Type ID
Primary B09921004270

Customer Contacts

Phone
800-821-7496

Premarket Submissions

Submission Number Supplement Number
K092544 000

Device Sizes

Type Value Unit Text
Length 3.375 Inch