AccessGUDID - DEVICE: Xenoscope 0° (00854490007007)

GUDID

Device Identifier (DI) Information

Brand Name: Xenoscope 0°
Version or Model: XS-0-1036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XS-0-1036
Company Name: XENOCOR, INC.

Primary DI Number: 00854490007007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080306345 *Terms of Use

Device Description: Xenoscope, 0°, 10mm x 36 cm

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?
43053	Rigid video laparoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.	Active	false
65872	Rigid-tip video laparoscope/thoracoscope, reusable	An electronic endoscope with a rigid distal tip intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity and the thoracic cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy and in the chest wall during thoracoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

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: 5d11bd7d-d8ef-4a5d-ac4d-ab524326ef20
Public Version Date: March 06, 2025
Public Version Number: 2
DI Record Publish Date: December 17, 2024

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES