FDA.reportPublic FDA data

REFLEX

Primary DI
10653405037101
Brand
REFLEX
Company
Conmed Corporation
Model
3031
Catalog number
3031
Device description
REFLEX EXTRACTOR WIDE/REGULAR
Published
2020-11-21
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
GDTSTAPLE, REMOVABLE (SKIN)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405037108PackageGS112Not in Commercial Distribution
10653405037101PrimaryGS10
00653405037104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503710820653405037108
1065340503710110653405037101
00653405037104006534050371046534050371040653405037104

GMDN Terms#

Term, Definition table
TermDefinition
Skin staple remover, single-useA hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.

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
12
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
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
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20197344111050MEDLINEMEDLINE INDUSTRIES, INC.GDT2025-03-05
10080196846924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
40080196846925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GDT2025-02-16
00192896120228Michel Wound ClipsSONTEC INSTRUMENTS, INC.GDT2024-10-15
14026704741943WECKTELEFLEX INCORPORATEDGDT2024-07-17
24026704741940WECKTELEFLEX INCORPORATEDGDT2024-07-17
04717480900374Taiwan SurgicalTAIWAN SURGICAL CORPORATIONGDT2023-08-02
04719880180493Haritex CorporationHARITEX CORPORATIONGDT2023-06-19
10841767102944Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
00841767102947Trinity Sterile, Inc.Trinity Sterile, Inc.GDT2023-03-09
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