FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319750735
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
404-597
Catalog number
404-597
Device description
Watson dermatome, fixed bar, complete with blade, 12" (30 cm)
Published
2023-03-21
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
GFDDermatome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319750735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319750735008403197507358403197507350840319750735

GMDN Terms#

Term, Definition table
TermDefinition
Skin grafting knifeA hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. 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
09348811000262INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000293INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000316INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811172082INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
06975808860160MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860177MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860184MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860191MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863000MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863017MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863024MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863031MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863048MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863055MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863062MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863079MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863086MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863093MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863109MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863116MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
08717903490501D100 dermatome setHumeca B.V.GFD2025-08-19
08717903490570Humeca D100 Dermatome bladeHumeca B.V.GFD2025-08-19
00860013994006TissueMillTISSUEMILL TECHNOLOGIES LLCGFD2025-05-29
06975808860412MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-05-24
08717903492352Micrograft gauze + cork plate, 1:3, 5-packHumeca B.V.GFD2025-05-20
08717903495421Humeca D42 Dermatome bladeHumeca B.V.GFD2025-05-20
08717903495414Humeca blade for Padgett® model B, C and S dermatomeHumeca B.V.GFD2025-05-20
08717903495407Humeca blade for Aesculap®/Acculan® dermatomeHumeca B.V.GFD2025-05-20
08717903495445Humeca blade for Zimmer® 8801-8821 dermatomeHumeca B.V.GFD2025-05-20
08717903490402D42 dermatome setHumeca B.V.GFD2025-05-20