AccessGUDID - DEVICE: Snowden-Pencer (10885403156830)

GUDID

Device Identifier (DI) Information

Brand Name: Snowden-Pencer
Version or Model: 89-8740
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89-8740
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403156830
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: SNOWDEN-PENCER LIGHT SOURCE 300 WATT XENON

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):	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?
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSS	Light, surgical, floor standing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961074	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 85255fed-4fe9-41ee-b4b0-d99cb373365d
Public Version Date: March 24, 2020
Public Version Number: 4
DI Record Publish Date: October 17, 2017