AccessGUDID - DEVICE: n.a. (04048551102268)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 26182TD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 26182TD
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551102268
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Changing Rod, ø 2.9 mm

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?
67280	Endoscope sheath exchange guide	An invasive device in the form of a thin, rigid rod intended to provide guidance for exchanging one endoscope sheath, which has been introduced into a patient, for another (e.g., exchange a transvaginal diagnostic sheath with an operative sheath). It is intended to be inserted into the lumen of the initial sheath to guide sheath retraction and remain in situ to guide replacement sheath introduction; the guide is removed once the replacement sheath is in place. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope accessories

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
No Device Sizes

Device Record Status

Public Device Record Key: a841e6b6-9f96-4baf-99da-30a732a7997a
Public Version Date: July 29, 2024
Public Version Number: 2
DI Record Publish Date: February 23, 2019

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

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