Identity
- Trade Name
- PeriAcryl®90 EUDAMEDPeriAcryl® FDA UDI
- Generic Name
- Clinical periodontal dressing FDA UDI
- Device Name
- PeriAcryl®90 EUDAMEDPeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings. FDA UDI
- Model / Reference
- P-ACRYL2(V)HV EUDAMEDFDA UDI
- Description
- PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings. FDA UDI
Identifiers
- Catalog Number
- P-ACRYL2(V)HV FDA UDI
- Primary DI / UDI-DI
- D795231 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D795038U EUDAMED
- 510(k) Number
- K071484 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q010304 PERIODONTAL DRESSINGS EUDAMED
- GMDN Term
- Clinical periodontal dressing FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
PeriAcryl®90 by GluStitch Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D795038U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GluStitch Inc.
- EUDAMED SRN
- CA-MF-000006943
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED a700bd79-ca19-4bb8-9589-6e79c4359467 61 fields · synced Jul 12, 2026
- FDA UDI 365c6f21-1b65-4f45-9986-0304db017dca 36 fields · synced May 30, 2026