FDA.reportPublic FDA data

JOHN HOPKINS BULLDOG CLAMP

Primary DI
00192896099890
Brand
JOHN HOPKINS BULLDOG CLAMP
Company
SONTEC INSTRUMENTS, INC.
Model
440-374
Catalog number
440-374
Device description
JOHN HOPKINS BULLDOG CLAMP
Published
2019-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123077000VASCULAR CLAMPSHebumedical GmbH2013-05-14DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896099890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896099890001928960998901928960998900192896099890

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.25Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24
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Primary DI, Brand, Company table
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04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13
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B8034906020ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
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ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15