PosiSep X2 0.8" x 2.3"

GUDID 00858439001910

PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.

HEMOSTASIS, LLC

Chitosan haemostatic agent, professional

Primary Device ID	00858439001910
NIH Device Record Key	4eb84958-c1de-4015-a21a-67c507526302
Commercial Distribution Status	In Commercial Distribution
Brand Name	PosiSep X2 0.8" x 2.3"
Version Model Number	9210615
Company DUNS	801380697
Company Name	HEMOSTASIS, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
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	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com
Phone	+1 651-855-1466
Email	customerservice@hemostasisllc.com

Device Dimensions

Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 Inch
Width	0.8 Inch
Length	2.3 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858439001903 [Primary]
GS1	00858439001910 [Package] Contains: 00858439001903 Package: Carton [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120958

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	2021-05-11
Device Publish Date	2021-05-03

Devices Manufactured by HEMOSTASIS, LLC

00858439001880 - PosiSep X2 0.7" x 1.7"	2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e
00858439001910 - PosiSep X2 0.8" x 2.3"	2021-05-11PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
00858439001910 - PosiSep X2 0.8" x 2.3"	2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e
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00858439001293 - NexStat Plus 2gm	2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001408 - NexStat Plus 3gm	2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide
00858439001439 - NexStat	2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th