FDA.reportPublic FDA data

Hu-Friedy

Primary DI
00889950077641
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
10-255-15
Catalog number
10-255-15
Device description
(Bx of 100) #15 Sterile Blade
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260159176148PrimaryGS10
04260159176155PrimaryGS10
10889950077648PrimaryGS10
00889950077641Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
04260159176148042601591761484260159176148
04260159176155042601591761554260159176155
1088995007764810889950077648
00889950077641008899500776418899500776410889950077641

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
100
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
true
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
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.CLAWMX2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.CLAWLX2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.CLAWXLX2026-04-06
10889950001643Hu-Friedy Mfg. Co., LLCPSN6953LPSN6953L2015-10-16
10889950001834Hu-Friedy Mfg. Co., LLCPSN7773LPSN7773L2015-10-16
10889950002060Hu-Friedy Mfg. Co., LLCPSNR683LPSNR683L2015-10-16
10889950002077Hu-Friedy Mfg. Co., LLCPSNR698LPSNR698L2015-10-16
10889950002084Hu-Friedy Mfg. Co., LLCPSNR7772LPSNR7772L2015-10-16
10889950156008Hu-FriedyIM53FMC22026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
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