DEVICE: Tri-Tech Forensics, Inc. (00869373000242)

Device Identifier (DI) Information

Tri-Tech Forensics, Inc.
RE-1MS
In Commercial Distribution

TRI-TECH FORENSICS, INC.
00869373000242
GS1

1
105878292 *Terms of Use
Tri-Tech Forensics Custom Sexual Assault Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
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?
35084 Victim sexual-assault forensic evidence kit
A collection of sterile devices and materials designed to be used during a forensic investigation to facilitate the acquisition of sexual-assault evidence from an alleged live victim. It typically includes devices to make and mail vaginal, rectal, and oral swabs and smears (e.g., cotton swabs with microscope slides and slide mailers); devices to collect samples of blood, saliva, and pubic hairs (e.g., blood collection tubes, filter paper disk, comb); containers (e.g., envelopes, bags) to collect pulled head/pubic hair, clothing, debris, and foreign material; and sometimes anatomical drawings and forms for medical history and consent. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K922343 000
No CLOSE

Sterilization

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

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

[?]
Size Type Text
Height: 2.375 Inch
Width: 6.75 Inch
Length: 10.25 Inch
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Device Record Status

27b3e5cc-3d71-41a9-975a-821f6e5f8109
March 04, 2020
1
February 25, 2020
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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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