DEVICE: Spectrum, Inc. (00850301007624)

Device Identifier (DI) Information

Spectrum, Inc.
982-03924-001M
In Commercial Distribution
781988M
SPECTRUM, INC.
00850301007624
GS1

1
080458964 *Terms of Use
Sterile Equipment Drape, Cordless Gama Probe, 1"X11.5"
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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?
45021 Instrument/equipment drape, single-use, sterile
A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, surgical
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

8562b597-e29d-4cf1-96c1-5996448570b6
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
00850301007631 50 00850301007624 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
Yes
No
No CLOSE

Customer Contact

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