AccessGUDID - DEVICE: Closer Vascular Sealing System (10857141005251)

GUDID

Device Identifier (DI) Information

Brand Name: Closer Vascular Sealing System
Version or Model: 202704
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 202704
Company Name: Rex Medical LLP

Primary DI Number: 10857141005251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 079535216 *Terms of Use

Device Description: No description.

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:	Yes
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?
46370	Femoral artery compression system, single-use	An assembly of sterile devices intended to be used in conjunction with manual compression to facilitate haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It typically consists of a dedicated catheter with an elastomeric membrane at the distal tip and a tensioner. The catheter is inserted through the previously placed catheter introducer sheath and, once positioned, the membrane is deployed in the inner lumen of the femoral artery. Tension is applied to keep the membrane against the arteriotomy while the natural mechanisms of haemostasis are enacted. Once haemostasis is achieved, this device is removed. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MGB	Device, Hemostasis, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 100 Degrees Fahrenheit
Handling Environment Temperature: less than 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed28e3a1-9697-4671-953c-0877a9564f26
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 28, 2017

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: 00857141005254 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: 610-940-0665
Email: sales@rexmedical.com

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