FDA.reportPublic FDA data

Kumar T-ANCHORS® Hernia Set

Primary DI
B361TA0080
Brand
Kumar T-ANCHORS® Hernia Set
Company
NASHVILLE SURGICAL INSTRUMENTS, LLC
Model
TA-008
Catalog number
TA-008
Device description
The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Hernia as Trans-fascial sutures, in addition to the tackers. Kumar T-ANCHORS® eliminate the need for grasping and feeding of sutures into a Suture Passer.
Published
2017-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081366000KUMAR T-ANCHORS HERNIA SETNashville Surgical Instruments2008-07-15GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B361TA0081PackageHIBCC10In Commercial Distribution
B361TA0080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical mesh T fastenerAn implantable device intended to be inserted percutaneously across the abdominal wall for trans-fascial fixation of a surgical mesh in the treatment of abdominal hernia. It consists of a metal T-bar with an attached non-bioabsorbable polymer suture, and includes appropriate introduction devices (e.g., needle, pusher stylet).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature45 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-382-4996orders@nashvillesurg.com

Regulatory Flags#

DUNS number
030096122
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B361CC0190Kumar Catheter®CC019CC-0192017-08-15
B361KC0020Kumar Clamp®KC-002KC-0022017-08-15
B361KC2XL0Kumar Clamp® for Single Port, Bariatrics and RoboticsKC2XLKC-2XL2017-08-15

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