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
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24
10845854015506CONMEDC2630C26302015-12-10

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