AccessGUDID - DEVICE: FastClamp - FastClamp System (05051986006628)

GUDID

Device Identifier (DI) Information

Brand Name: FastClamp - FastClamp System
Version or Model: IC-1000-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURGICAL INNOVATIONS LIMITED

Primary DI Number: 05051986006628
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 771051935 *Terms of Use

Device Description: Instrument Clamp Assembly

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?
37050	Medical table clamp	A device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. 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 [?]
K100442	000

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: 12932b34-b786-4820-b187-560448e43ed8
Public Version Date: March 31, 2020
Public Version Number: 3
DI Record Publish Date: September 23, 2016