AccessGUDID - DEVICE: PILLING (04026704649822)

GUDID

Device Identifier (DI) Information

Brand Name: PILLING
Version or Model: IPN029621
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 527868
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704649822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: LC FOR 522196 GARRETT-OSSOFF-PILLING

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":	Yes
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?
48036	Surgical instrument fibreoptic light	A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EQH	SOURCE, CARRIER, FIBEROPTIC LIGHT

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 145 Millimeter

Device Record Status

Public Device Record Key: 19be6f24-f70e-4917-89b5-f748d85277ee
Public Version Date: February 04, 2020
Public Version Number: 1
DI Record Publish Date: January 27, 2020