DEVICE: AVID TruCustom (10809160126196)

Device Identifier (DI) Information

AVID TruCustom
HSAM027-04_0001
In Commercial Distribution
HSAM027-04
AVID MEDICAL, INC.
10809160126196
GS1

1
015623119 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use A collection of various sterile surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical procedure; it does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OKV Obstetrical kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

d0f10ef1-2bdb-4c6f-9b6a-d32750cc276f
September 13, 2018
3
February 06, 2017
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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
20809160126193 10 10809160126196 In Commercial Distribution
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888) 564-7153
AVIDComplaints@Owens-Minor.com
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