AccessGUDID - DEVICE: Procedure Pack (07640167750153)

GUDID

Device Identifier (DI) Information

Brand Name: Procedure Pack
Version or Model: 8.5/140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 510.701.114
Company Name: SIE AG, Surgical Instrument Engineering

Primary DI Number: 07640167750153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482163628 *Terms of Use

Device Description: Procedure Pack Ø 8.5mm, 140µm flap thickness

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNO	Keratome, Ac-Powered
GEX	Powered Laser Surgical Instrument
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053511	000
K112154	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Height: 140 Micrometer
Lumen/Inner Diameter: 8.5 Millimeter

Device Record Status

Public Device Record Key: 9cfcd5e0-76dd-451c-9b26-fd3fc8398f40
Public Version Date: November 08, 2019
Public Version Number: 2
DI Record Publish Date: September 14, 2018