DEVICE: Spectrum, Inc. (00850301007655)

Device Identifier (DI) Information

Spectrum, Inc.
982-03561-000
In Commercial Distribution
706920NS
SPECTRUM, INC.
00850301007655
GS1

1
080458964 *Terms of Use
Equipment Drape, UniversaL Camera, 7" X 96", non-sterile
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61049 Instrument/equipment drape, single-use, non-sterile
A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MMP Cover, barrier, protective
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K934630 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f541d7b6-ccf3-42ca-8135-7ec5d31b7e5e
July 06, 2018
3
January 30, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10850301007652 100 00850301007655 In Commercial Distribution shipper
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(214)492-0506 3
hfahrlander@spectrumlabs.com
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