AccessGUDID - DEVICE: DeBakey-Satinsky Vena Cava Clamp 24.5cm (04057034055564)

GUDID

Device Identifier (DI) Information

Brand Name: DeBakey-Satinsky Vena Cava Clamp 24.5cm
Version or Model: 22-0390
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22-0390
Company Name: Geister Medizintechnik GmbH

Primary DI Number: 04057034055564
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343548848 *Terms of Use

Device Description: DeBakey-Satinsky Vena Cava Clamp 24.5cm

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Vascular clamp, reusable	A hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-retaining, scissors-like design with ring handles; the working end has blades of various designs (e.g., curved, angled, semicircular) specific for different applications. It is available in various sizes, is typically made of high-grade stainless steel, and may utilize inserts made of various materials (e.g., carbide, silicone). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Vascular clamp, reusable

A hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-retaining, scissors-like design with ring handles; the working end has blades of various designs (e.g., curved, angled, semicircular) specific for different applications. It is available in various sizes, is typically made of high-grade stainless steel, and may utilize inserts made of various materials (e.g., carbide, silicone). This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
DXC	CLAMP, VASCULAR

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: No
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: b87bd1f0-af4c-4d0d-a5bc-dc39305d0148
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016