DEVICE: Hu-Friedy (10889950002169)

Device Identifier (DI) Information

Hu-Friedy
IMS-1347
In Commercial Distribution
IMS-1347
HU-FRIEDY MFG. CO., LLC
10889950002169
GS1

200
005085972 *Terms of Use
IMS Bagette 2.75" x 9" 200 Pouches
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58968 Instrument management bag
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KCT Sterilization wrap containers, trays, cassettes & other accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070428 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 95 Degrees Fahrenheit
Storage Environment Humidity: less than 70 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3ed1c344-b993-48d9-af43-c478ecf18596
November 06, 2020
4
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 10889950035358 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)483-7433
info@hu-friedy.com
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