FDA.reportPublic FDA data

Hu-Friedy Mfg. Co., LLC

Primary DI
10889950000370
Brand
Hu-Friedy Mfg. Co., LLC
Company
HU-FRIEDY MFG. CO., LLC
Model
PSN612A
Catalog number
PSN612A
Device description
3-0 PLAIN GUT SUTURE 18", C-9 NEEDLE 23MM, 1/2 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
OTC
false
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
10889950000370PackageGS112In Commercial Distribution
10889950001032PackageGS13In Commercial Distribution
10889950001483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000037010889950000370
1088995000103210889950001032
1088995000148310889950001483

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA sterile, single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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 needle intended to be disposed of after single use. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005085972
Device count
1
DM exempt
false
Premarket exempt
false
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
10889950156008Hu-FriedyIM53FMC22026-03-05
10889950156015Hu-FriedyIM56FMC22026-03-05
10889950155445Hu-FriedyIM4160C4AF2026-02-26
10889950155452Hu-FriedyIM4162C4AF2026-02-26
10889950155469Hu-FriedyIM4163C4AF2026-02-26
10889950155476Hu-FriedyIM4165C4AF2026-02-26
10889950155483Hu-FriedyIM4166C4AF2026-02-26
10889950155490Hu-FriedyIM4168C4AF2026-02-26
10889950155506Hu-FriedyIM4169C4AF2026-02-26
10889950154714Hu-FriedyIM8125E1L2026-02-18
10889950154721Hu-FriedyIM8126E1L2026-02-18
10889950154738Hu-FriedyIM8128E1L2026-02-18
10889950154745Hu-FriedyIM8129E1L2026-02-18
10889950154752Hu-FriedyIM4225LP32026-02-18
10889950154769Hu-FriedyIM4226LP32026-02-18
10889950154776Hu-FriedyIM4228LP32026-02-18
10889950154783Hu-FriedyIM4229LP32026-02-18
10889950154790Hu-FriedyIM4220LP32026-02-18
00889950143285PWR Classic PowderAP-CN2024-09-06

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Primary DI, Brand, Company table
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D765GC3019751X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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D765GC3019P751X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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D765GC5016P451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
D765GC5019451X-Gut™ Chromic Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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D765GP3019751X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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D765GP3024751X-Gut™ Plain Gut SutureOsteogenics Biomedical IncGAL2025-09-01
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