Identity
- Trade Name
- Spectrum, Inc. FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, sterile FDA UDI
- Device Name
- Sterile Equipment Drape, ACUSON, 5" X 72" FDA UDI
- Model / Reference
- 982-03813-000 FDA UDI
- Description
- Sterile Equipment Drape, ACUSON, 5" X 72" FDA UDI
Identifiers
- Catalog Number
- 956920WOLF FDA UDI
- Primary DI / UDI-DI
- 00850301007297 FDA UDI
- 510(k) Number
- K934630 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Instrument/equipment drape, single-use, sterile
Spectrum, Inc. by Spectrum Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument/equipment drape, single-use, sterile.
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- UNBRANDED — Advance Medical Designs, Inc. · Class II
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Cleared under the same submission
K934630 also covers:
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
- Spectrum, Inc. — Spectrum Co.
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
- Spectrum Co.
Sources (1)
- FDA UDI 3fd43d04-46fc-4f2f-a905-8faa9adcba3b 36 fields · synced May 30, 2026