FDA.reportPublic FDA data

AtriClip® Selection Guide

Primary DI
10840143919350
Brand
AtriClip® Selection Guide
Company
ATRICURE, INC.
Model
CGG100
Catalog number
A000349-16
Device description
Selection Guide
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143919354PackageGS11In Commercial Distribution
50840143919358PackageGS136In Commercial Distribution
10840143919350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391935430840143919354
5084014391935850840143919358
1084014391935010840143919350

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
866-449-2342SEhlert@atricure.com

Regulatory Flags#

DUNS number
006133784
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143912788cryoICE®CRYO2A0015602026-09-29
10840143912795cryoICE®CRYO3A0015612026-09-29
10840143912801cryoICE® cryoFORM™CRYOFA0015622026-09-29
10840143912832Cannula with GuideCSK-6131CSK-6131-32026-05-31
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250337121060Coupling nut for endoscope adapterJoimax GmbHFZX2026-10-29
04250337121077Adapter holderJoimax GmbHFZX2026-10-29
04250337121183Locking screw for endoscope adapterJoimax GmbHFZX2026-10-29
04250337122425Endoscope Adapter for LaminoscopeJoimax GmbHFZX2026-10-29
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119227Counter Pusher, yellowJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22