FDA UDI
In Commercial Distribution
🇺🇸 United States
ATRAMAT
DI: 07500142000706
·
Model: CHROMIC GUT
·
Internacional Farmacéutica, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ATRAMAT
- Primary DI
- 07500142000706
- Version / Model
- CHROMIC GUT
- Catalog Number
- G3713-75
- Company Name
- Internacional Farmacéutica, S.A. de C.V.
- Labeler DUNS
- 811313428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 0ee42b56-621f-425d-bf92-b13bfc584d4c
- Distribution End Date
- 2040-12-31
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | 878.4830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45045 | Rigid optical intracranial/spinal endoscope, single-use | An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle; it does not include video imaging capability, however, might be used with a separate video camera for optional video image viewing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07500142100703 | GS1 | DOZEN | 12 | In Commercial Distribution | 2040-12-31 |
| Primary | 07500142000706 | GS1 | ||||
| Package | 07500142200700 | GS1 | BOX WITH 24 PACKS | 24 | In Commercial Distribution | 2040-12-31 |
Customer Contacts
- Phone
- +525511050260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K911354 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 37 | Millimeter | |
| Device Size Text, specify | USP 3-0 EP 3 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius