FDA.reportPublic FDA data

REFLEX

Primary DI
30653405074810
Brand
REFLEX
Company
Conmed Corporation
Model
530
Catalog number
530
Device description
REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBTAPPLIER, HEMOSTATIC CLIP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBTApplier, Hemostatic ClipGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924929000REFLEX(R) ECARichard-Allan Medical1993-07-21HBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405074813PackageGS16Not in Commercial Distribution
30653405074810PrimaryGS10
00653405074819Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340507481320653405074813
3065340507481030653405074810
00653405074819006534050748196534050748190653405074819

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
6
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661522100882Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100899Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100905Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100929Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100936Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100912Applier, hemostatic clipPETERS SURGICALHBT2023-12-28
03661522039540Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039557Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039564Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039571Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039588Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039595Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039601Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039649Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039656Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039663Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039670Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039687Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039694Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039700Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039717Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039724Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039731Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039748Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039755Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039762Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039786Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039793Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039809Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039816Applier, hemostatic clipPETERS SURGICALHBT2023-06-08