NexPak X

GUDID 00858439001644

NexPak X Intranasal Splint is a sterile flexible foam pad comprised of a lyophilized mixture of starch polysaccharide and polysaccharide binders. NexPak X Intranasal Splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and nasal cavity. The intranasal splint is placed in the nasal cavity after surgery or trauma.

HEMOSTASIS, LLC

Intranasal splint, non-biodegradable

Primary Device ID	00858439001644
NIH Device Record Key	9a6b6ba0-42aa-4bea-b3bb-9f2c88339591
Commercial Distribution Status	In Commercial Distribution
Brand Name	NexPak X
Version Model Number	9110534
Company DUNS	801380697
Company Name	HEMOSTASIS, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com
Phone	+6518551466
Email	customerservice@hemostasisllc.com

Device Dimensions

Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch
Length	2 Inch
Width	0.6 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858439001637 [Primary]
GS1	00858439001644 [Package] Contains: 00858439001637 Package: Carton [5 Units] In Commercial Distribution

FDA Product Code

LYA	Splint, Intranasal Septal

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-10-08
Device Publish Date	2020-09-30

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