AccessGUDID - DEVICE: SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO (M648C0100120)

GUDID

Device Identifier (DI) Information

Brand Name: SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO
Version or Model: C010012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OBP CORPORATION

Primary DI Number: M648C0100120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011560431 *Terms of Use

Device Description: C010012 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO (Customer REF 27550ZAG/10)

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:	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?
60650	Endoscope working-channel seal	A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)
HIH	Hysteroscope (And Accessories)
ODC	Endoscope Channel Accessory

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: fbc70530-cc47-4b13-bf38-b5a3a822fd9d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 11, 2016