FDA.reportPublic FDA data

REFLEX

Primary DI
20653405048388
Brand
REFLEX
Company
Conmed Corporation
Model
3036
Catalog number
3036
Device description
Reflex One, Skin Stapler, 35 wide
Published
2020-11-13
Public version status
Update
Distribution status
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
FZQCLIP, REMOVABLE (SKIN)
QQSStapler, skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1
QQSStapler, SkinGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405048381PackageGS16In Commercial Distribution
20653405048388PrimaryGS10
00653405048384Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340504838110653405048381
2065340504838820653405048388
00653405048384006534050483846534050483840653405048384

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

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
Premarket exempt
true
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
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
06946480584057Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-05-13
06946480584026Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584040Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584118Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584125Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584132Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584149Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584156Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584064Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
06946480584163Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
00867469000244SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
10867469000241SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
06974600043207KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043214KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043221KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043238KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043245KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043252KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043269KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043276KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043283KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043290KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043306KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043313KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043320KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043337KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043204KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043211KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043228KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043235KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28