FDA.reportPublic FDA data

Hu-Friedy Mfg. Co., LLC

Primary DI
10889950001520
Brand
Hu-Friedy Mfg. Co., LLC
Company
HU-FRIEDY MFG. CO., LLC
Model
PSN635C
Catalog number
PSN635C
Device description
"4-0 CHROMIC GUT SUTURE 27"", C-6 NEEDLE 18.7MM, 3/8 CIRCLE REVERSE CUT"
Published
2015-10-16
Public version status
Update
Distribution status
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
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950000417PackageGS112In Commercial Distribution
10889950001056PackageGS13In Commercial Distribution
10889950001520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000041710889950000417
1088995000105610889950001056
1088995000152010889950001520

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
005085972
Device count
1
Lot or batch
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
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