AccessGUDID - DEVICE: n.a. (04048551393802)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 26159LC-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551393802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: LOOP,SPARE, STERILE, BETTOCCHI

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:	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?
36176	Polypectomy endoscopic ligator, reusable	A device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	HYSTEROSCOPE (AND ACCESSORIES)

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: b87bf013-83fe-42c2-98b2-8268e0c76984
Public Version Date: October 21, 2024
Public Version Number: 4
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: 04048551393819 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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