FDA UDI
In Commercial Distribution
🇺🇸 United States
Tri-Tech Forensics, Inc.
DI: 00869373000242
·
Model: RE-1MS
·
TRI-TECH FORENSICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tri-Tech Forensics, Inc.
- Primary DI
- 00869373000242
- Version / Model
- RE-1MS
- Company Name
- TRI-TECH FORENSICS, INC.
- Labeler DUNS
- 105878292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- 27b3e5cc-3d71-41a9-975a-821f6e5f8109
Device Description
Tri-Tech Forensics Custom Sexual Assault Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869373000242 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922343 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 2.375 | Inch | |
| Width | 6.75 | Inch | |
| Length | 10.25 | Inch |