Identity
- Trade Name
- ATRAMAT FDA UDI
- Generic Name
- Rigid optical intracranial/spinal endoscope, single-use FDA UDI
- Model / Reference
- CHROMIC GUT FDA UDI
Identifiers
- Catalog Number
- G3713-75 FDA UDI
- Primary DI / UDI-DI
- 07500142000706 FDA UDI
- 510(k) Number
- K911354 FDA UDI
- FDA Product Code
- GAL FDA UDI
- GMDN Term
- Rigid optical intracranial/spinal endoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 37 Millimeter FDA UDI
Category: Rigid optical intracranial/spinal endoscope, single-use
Atramat by Internacional Farmacéutica S.A DE C.V — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical intracranial/spinal endoscope, single-use.
- ChannelScope, Long, 10K — CLARUS MEDICAL, LLC · Class II
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class I
- NeuroPEN — Medtronic PS Medical · Class II
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- Aurora® Surgiscope® — Integra Lifesciences Corp. · Class II
- AURORA® Surgiscope® — REBOUND THERAPEUTICS, CORPORATION · Class I
Cleared under the same submission
K911354 also covers:
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
- ATRAMAT — Internacional Farmacéutica S.A DE C.V
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Internacional Farmacéutica S.A DE C.V
Sources (1)
- FDA UDI 0ee42b56-621f-425d-bf92-b13bfc584d4c 38 fields · synced May 30, 2026