Identity
- Trade Name
- PosiSep X2 0.8" x 2.3" FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 9210615 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858439001903 FDA UDI
- FDA Product Code
- LYA FDA UDIEMX FDA UDIFRO FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4780 FDA UDI874.4100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 0.8 Inch FDA UDILength — 2.3 Inch FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep X2 0.8" x 2.3" by Hemostasis, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
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- HemCon ChitoGauze XR2 Pro, 3in x 4yd — Tricol Biomedical, INC. · U
- QUIKCLOT — TELEFLEX INCORPORATED · U
- CELOX Gauze — Medtrade Products , Ltd. · U
- HemCon® OneStop™ Bandage, 2in x 2in — Tricol Biomedical, INC. · U
- CELOX Vascular — Medtrade Products , Ltd. · U
- Axiostat Patch — Advamedica, Inc. · U
- GuardaCare® PRO, 4in x 4in, 8ply — Tricol Biomedical, INC. · U
Cleared under the same submission
K120958 also covers:
- PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X2 0.7" x 1.7" — Hemostasis, LLC
K122494 also covers:
- PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep C — Hemostasis, LLC
- PosiSep C 0.6 x 2.0 — Hemostasis, LLC
- PosiSep C² — Hemostasis, LLC
- PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint — Hemostasis, LLC
- PosiSep X2 0.7" x 1.7" — Hemostasis, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hemostasis, LLC
Sources (1)
- FDA UDI 4eb84958-c1de-4015-a21a-67c507526302 37 fields · synced May 30, 2026