Celt ACD Vascular Closure Device 5F_ESP

GUDID 05391530280037

Celt ACD Vascular Closure Device 5F_ESP

VASORUM LIMITED

Vascular closure clip
Primary Device ID05391530280037
NIH Device Record Key3a4c1a4c-3bc5-4d53-9b5c-b9452f6ff91a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelt ACD Vascular Closure Device 5F_ESP
Version Model NumberKCLT-05
Company DUNS896197592
Company NameVASORUM LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French
Catheter Gauge5 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep out of direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105391530280037 [Primary]
GS105391530280044 [Package]
Package: Inner Carton [5 Units]
In Commercial Distribution
GS105391530280051 [Package]
Contains: 05391530280044
Package: Shipper Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGBDevice, Hemostasis, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-21

Devices Manufactured by VASORUM LIMITED

05391530280006 - Celt ACD Vascular Closure Device 5F2018-07-06 Celt ACD Vascular Closure Device 5F
05391530280037 - Celt ACD Vascular Closure Device 5F_ESP2018-07-06Celt ACD Vascular Closure Device 5F_ESP
05391530280037 - Celt ACD Vascular Closure Device 5F_ESP2018-07-06 Celt ACD Vascular Closure Device 5F_ESP
05391530280068 - Celt ACD Vascular Closure Device 6F2018-07-06 Celt ACD Vascular Closure Device 6F
05391530280099 - Celt ACD Vascular Closure Device 6F_ESP2018-07-06 Celt ACD Vascular Closure Device 6F_ESP
05391530280129 - Celt ACD Vascular Closure Device 7F2018-07-06 Celt ACD Vascular Closure Device 7F
05391530280150 - Celt ACD Vascular Closure Device 7F_ESP2018-07-06 Celt ACD Vascular Closure Device 7F_ESP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.