AccessGUDID - DEVICE: Celt ACD Vascular Closure Device 6F (05391530280068)

GUDID

Device Identifier (DI) Information

Brand Name: Celt ACD Vascular Closure Device 6F
Version or Model: KCLT-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VASORUM LIMITED

Primary DI Number: 05391530280068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 896197592 *Terms of Use

Device Description: Celt ACD Vascular Closure Device 6F

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
63225	Implantable vascular closure clip	A non-bioabsorbable metallic clip intended to be implanted following a percutaneous catheterization procedure to close the punctured access site on an artery (typically femoral) and improve haemostasis. It is typically a small circular clip with grasping blades intended to close inwardly upon deployment; dedicated disposable devices (e.g., applicator) intended for implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MGB	Device, Hemostasis, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150006	001

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
Special Storage Condition, Specify: Keep Dry. Keep out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 7c455681-c2e4-4b60-a32b-315eec0169ce
Public Version Date: October 21, 2020
Public Version Number: 4
DI Record Publish Date: July 21, 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
05391530280075	5	05391530280068		In Commercial Distribution	Inner Carton
05391530280082	4	05391530280075		In Commercial Distribution	Shipper Carton

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

[?]

No Customer Contact currently defined

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