AccessGUDID - DEVICE: N/A (00885825012557)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 174317
Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.

Primary DI Number: 00885825012557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020198912 *Terms of Use

Device Description: Endo Clinch II w/On-Off Ratchet Switch

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?
61838	Rigid endoscopic tissue manipulation forceps, reprocessed	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWV	Laparoscopic accessories, gynecologic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -22 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: 5f0939fb-ac7f-467e-9521-f1eecbc214e9
Public Version Date: December 18, 2023
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
30885825012558	6	00885825012557		In Commercial Distribution	pack

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)888-3433
Email: RegulatoryAffairs2@stryker.com

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