AccessGUDID - DEVICE: Spectrum, Inc. (00855495007320)

GUDID

Device Identifier (DI) Information

Brand Name: Spectrum, Inc.
Version or Model: 982-03725-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 956925TET
Company Name: SPECTRUM, INC.

Primary DI Number: 00855495007320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080458964 *Terms of Use

Device Description: Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
LPZ	Container, frozen donor tissue storage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934630	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a729fdcf-6df9-482e-a73c-80fbef2a0f8a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 21, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20855495007324	20	10855495007327		In Commercial Distribution	Shipper
10855495007327	10	00855495007320		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(214)492-0506 ext: 3
Email: hfahrlander@spectrumlabs.com

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