FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950002169
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
IMS-1347
Catalog number
IMS-1347
Device description
"IMS Bagette 2.75"" x 9"" 200 Pouches"
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070428000MEDICOM SELF-SEALING STERILIZATION POUCHA.R. Medicom, Inc.2007-07-17KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950002169PrimaryGS10
10889950035358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000216910889950002169
1088995003535810889950035358

GMDN Terms#

Term, Definition table
TermDefinition
Instrument management bag, non-sterileA non-sterile flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity070 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005085972
Device count
200
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157623Hu-FriedyI1308CE2LP2026-07-28
10889950157562Hu-FriedyIMN4120C22026-07-13
10889950157579Hu-FriedyIMN4122C22026-07-13
10889950154066PWR AirAPAIRPOL2026-01-14
10889950154080HuFriedyGroupDAPAIRPOL2026-01-14
10889950154103HuFriedyGroupLAPAIRPOL2026-01-14
10889950157517Hu-FriedyIMN4120C2F2026-06-23
10889950157524Hu-FriedyIMN4122C2F2026-06-23
10889950157531Hu-FriedyIMN4128C2F2026-06-23
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

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