Spectrum, Inc. 982-03954-001
by Spectrum Co.
Spectrum, Inc. 982-03954-001 (SD-100) is a device classified as Unclassified made by Spectrum Co., cleared under FDA 510(k) K934630 on 28 Oct 1994 and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 00855495007351), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00855495007351 | Date21 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK934630 | Date28 Oct 1994 | StatusActive |
Official records
- AccessGUDID record 00855495007351
- FDA 510(k) database K934630
Across registries
- FDA 510(k) K934630 decided 28 Oct 1994 Active
- FDA GUDID UDI-DI 00855495007351 listed 21 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K934630
- Listed FDA GUDID 00855495007351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spectrum, Inc.
- Generic name
- Medical equipment/instrument drape, single-use
- Model / Ref / Catalog
- 982-03954-001, SD-100
- Primary DI / UDI-DI
- 00855495007351
- 510(k) Number
- FDA product code
- LPZ
- GMDN term
- Medical equipment/instrument drape, single-use
- Device class
- U
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Safe
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