FDA.reportPublic FDA data

REFLEX

Primary DI
20653405037238
Brand
REFLEX
Company
Conmed Corporation
Model
853590
Catalog number
853590
Device description
REFLEX ONE SKIN STAPLER, 35 WIDE: FURTHER PROCESSING REQUIRED
Published
2021-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZQCLIP, REMOVABLE (SKIN)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405037238PrimaryGS10
00653405037234Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503723820653405037238
00653405037234006534050372346534050372340653405037234

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, non-bioabsorbableA hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00842331160783Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
00842331163944Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
20653405037252REFLEXConmed CorporationFZQ2021-10-14
20653405047091CONMED REFLEXConmed CorporationFZQ2021-10-14
00653405037234REFLEXConmed CorporationFZQ2021-10-14
00653405037258REFLEXConmed CorporationFZQ2021-10-14
30653405047098CONMED REFLEXConmed CorporationFZQ2021-10-14
00850010207094BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
00850010207193BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
10850010207091BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
20653405036927REFLEXConmed CorporationFZQ2020-11-13
20653405036958REFLEXConmed CorporationFZQ2020-11-13
20653405036989REFLEXConmed CorporationFZQ2020-11-13
20653405037016REFLEXConmed CorporationFZQ2020-11-13
20653405048388REFLEXConmed CorporationFZQ2020-11-13
20653405050596REFLEXConmed CorporationFZQ2020-11-13
20653405050602REFLEXConmed CorporationFZQ2020-11-13
20653405050893REFLEXConmed CorporationFZQ2020-11-13
10653405036920REFLEXConmed CorporationFZQ2020-11-13
10653405036951REFLEXConmed CorporationFZQ2020-11-13
10653405036982REFLEXConmed CorporationFZQ2020-11-13
10653405037019REFLEXConmed CorporationFZQ2020-11-13
10653405048381REFLEXConmed CorporationFZQ2020-11-13
10653405050599REFLEXConmed CorporationFZQ2020-11-13
10653405050605REFLEXConmed CorporationFZQ2020-11-13
10653405050896REFLEXConmed CorporationFZQ2020-11-13
04046826020392MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020408MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020415MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020422MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24