FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950132033
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
IMS3116AW2
Catalog number
IMS3116AW2
Device description
DD 16-Instr Resin Cass, 2 A/W Clips
Published
2021-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950132033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995013203310889950132033

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410956Hu-FriedySSC-KIT2026-10-20
08800012411038Hu-FriedySSC-URD22026-10-20
08800012411182Hu-FriedySSC-LRD52026-10-20
08800012411199Hu-FriedySSC-LRD62026-10-20
08800012411205Hu-FriedySSC-LRD72026-10-20
08800012411212Hu-FriedySSC-ULE22026-10-20
08800012411229Hu-FriedySSC-ULE32026-10-20
08800012411236Hu-FriedySSC-ULE42026-10-20
08800012411243Hu-FriedySSC-ULE52026-10-20
08800012411250Hu-FriedySSC-ULE62026-10-20
08800012411267Hu-FriedySSC-ULE72026-10-20
08800012411397Hu-FriedySSC-LRE22026-10-20
08800012411403Hu-FriedySSC-LRE32026-10-20
08800012411410Hu-FriedySSC-LRE42026-10-20
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699885IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21
00889024699939N/AZimmer, Inc.FSM2026-10-20
00889024699946N/AZimmer, Inc.FSM2026-10-20
00889024699953Alliance Glenoid, Identity HumeralZimmer, Inc.FSM2026-10-20
00810111228428Instrument TrayTreace Medical Concepts, Inc.FSM2026-10-16
00810161900909EARP IMPLANT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900916EARP INSTRUMENT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900923EARP INSTRUMENT AND IMPLANT LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900930EARP RETRACTOR TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900947EARP RETRACTOR LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900954EARP, TRIAL CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900961EARP, TRIAL LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900978EARP, DISC SPACER CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900985EARP, DISC SPACER LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901746EARP INSTRUMENT #2 TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901753EARP INSTRUMENT #2 LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901814EARP, PLATFORM CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901821EARP, PLATFORM LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
04042409457203CHBSaap Implantate AGFSM2026-10-16
04042409457289CHBSaap Implantate AGFSM2026-10-16
04042409457302CHBSaap Implantate AGFSM2026-10-16
04042409457326CHBSaap Implantate AGFSM2026-10-16
04042409457340CHBSaap Implantate AGFSM2026-10-16