FDA.reportPublic FDA data

8mm x 8mm Staple System

Primary DI
00812926027500
Brand
8mm x 8mm Staple System
Company
Trilliant Surgical, LLC
Model
500-08-001
Device description
8mm Sniper Sterile Staple Kit
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162354000Sniper Staple SystemTrilliant Surgical, Ltd.2017-04-20JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926027500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926027500008129260275008129260275000812926027500

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Millimeter
Width8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828829072
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00810028395251Arsenal Foot300-82-0162024-03-21

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