FDA.reportPublic FDA data

REFLEX

Primary DI
00653405037258
Brand
REFLEX
Company
Conmed Corporation
Model
873590
Catalog number
873590
Device description
REFLEX TL SKIN STAPLER WITH TISSUE LIFT, 35 WIDE: FURTHER PROCESSING REQUIRED
Published
2021-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZQCLIP, REMOVABLE (SKIN)
GAGStapler, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1
GAGStapler, SurgicalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405037252PrimaryGS10
00653405037258Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503725220653405037252
00653405037258006534050372586534050372580653405037258

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

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

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703797Tri-Staple 2.0Covidien LPGAG2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGAG2026-07-31
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000378TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000538TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000545TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000576TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000583TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27