FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319701317
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
033-028
Catalog number
033-028
Device description
Keyes Dermal Biopsy Punch 4" (10cm), 8mm, stainless
Published
2022-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRYPUNCH, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319701317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319701317008403197013178403197013170840319701317

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

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
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
00840319723944Hayden Medical300-007300-0072022-08-16
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08681506800138SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800145SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
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08681506800169SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800176SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800183SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800190SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800206SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800213SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800220SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800237SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800244SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800251SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800015SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800022SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800039SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800046SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800053SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800084SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
04262494460029N/ADoppkon GmbH & Co. KGLRY2025-12-04