AccessGUDID - DEVICE: Spectroline (00672052155276)

GUDID

Device Identifier (DI) Information

Brand Name: Spectroline
Version or Model: Q-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102
Company Name: SPECTRONICS CORPORATION

Primary DI Number: 00672052155276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002044410 *Terms of Use

Device Description: Two 4-Watt Integrally Filtered UV-A Tubes Woods Lamp

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
36941	Wood's lamp	A light designed to emit ultraviolet light (at a wavelength of approximately 365 nm) to illuminate parts of the body to observe fluorescence for diagnostic purposes. It is typically used to help diagnose dermal fungal infections (e.g., Microsporum audouini), bacterial infections (e.g., Corynebacterium minutissimum, Pseudomonas), parasitic infections (e.g., scabies), and pigmentary disorders (e.g., vitiligo). It also often used to examine rape victims for sperm residues or examine a patient's eyes for corneal lesions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 1faea73f-88ec-4229-82b2-145446dc873f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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