FDA.reportPublic FDA data

Gynex

Primary DI
GYNX13100
Brand
Gynex
Company
GYNEX CORPORATION
Model
1310
Published
2023-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMEPunch, Biopsy, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX13101PrimaryHIBCC0
GYNX13100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012997685
Device count
6
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10649111228056Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111228919Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111229817Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
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10649111231421Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233159Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233500Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233784Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111234101Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111231422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233150Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233501Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111234102Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111082726Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234378Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234675Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111235078Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111236594Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111072949Sklar InstrumentsSKLAR CORPORATIONEME2025-11-06
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28