AccessGUDID - DEVICE: n.a. (04048551083802)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 24941F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24941F
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551083802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Sealing cap with window

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?
63886	Rigid endoscope proximal observation cap	A noninvasive, light-penetrating device with a transparent observation window intended to be mounted onto the proximal end of a rigid endoscope to provide an airtight seal (e.g., for inflation of the bowel), while facilitating visibility of the examined/treated area through the endoscope. It may include a port intended to accept an adaptor for connecting a fibre optic cable. It does not include an instrument port; the detachable adaptor and cable are not included with the cap. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCF	PROCTOSCOPE

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: 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: 5416e10f-f14c-4b50-8b99-adc54a55803d
Public Version Date: October 21, 2024
Public Version Number: 6
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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +14242188201
Email: regulatory@karlstorz.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES