FDA.reportPublic FDA data

CONEMD

Primary DI
20653405037221
Brand
CONEMD
Company
Conmed Corporation
Model
803590
Catalog number
803590
Device description
REFLEX ONE SKIN STAPLER, 35 REGULAR: FURTHER PROCESSING REQUIRED
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
20653405037221PackageGS150In Commercial Distribution
30653405037228PrimaryGS10
00653405037227Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503722120653405037221
3065340503722830653405037228
00653405037227006534050372276534050372270653405037227

GMDN Terms#

Term, Definition table
TermDefinition
Skin staplerA sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@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
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
20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282890McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282913McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283194McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283200McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10888277368293MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14
10888277378872MEDLINEMEDLINE INDUSTRIES, INC.GAG2025-02-14
10884521827639EEACovidien LPGAG2025-02-07
10884521827646EEACovidien LPGAG2025-02-07
10884521827653EEACovidien LPGAG2025-02-07
10884521827660EEACovidien LPGAG2025-02-07
10884521703735Tri-Staple 2.0Covidien LPGAG2024-11-29
10884521703759Tri-Staple 2.0Covidien LPGAG2024-11-29
10884521703773Tri-Staple 2.0Covidien LPGAG2024-11-29
10884521845480SigniaCovidien LPGAG2024-11-29
10884521845497SigniaCovidien LPGAG2024-11-29
00850060791062AEONLEXINGTON MEDICAL, INC.GAG2024-06-05
00850060791079AEONLEXINGTON MEDICAL, INC.GAG2024-06-05
00850060791086AEONLEXINGTON MEDICAL, INC.GAG2024-06-05
00850060791031AEONLEXINGTON MEDICAL, INC.GAG2024-05-24
00850060791048AEONLEXINGTON MEDICAL, INC.GAG2024-05-24