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Acu-Dispo-Curette
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R0125Ref R0250Ref R0710Ref R0425Ref R0150Ref R0210Ref R0700Ref R0725Ref R0325Ref R0110Ref R0550Ref R0200Ref R0750Ref R0310
Identity
- Trade Name
- Acu-Dispo-Curette EUDAMEDFDA UDI
- Generic Name
- Dermal curette, single-use FDA UDI
- Device Name
- ACU-DISPO-CURETTE EUDAMEDAcu-Dispo-Curette 1mm cup FDA UDI
- Model / Reference
- R0125 EUDAMEDR0250 EUDAMEDR0710 EUDAMEDR0425 EUDAMEDR0150 EUDAMEDR0210 EUDAMEDR0700 EUDAMEDR0725 EUDAMEDR0325 EUDAMEDR0110 EUDAMEDR0550 EUDAMEDR0200 EUDAMEDR0750 EUDAMEDR0310 EUDAMEDR01 FDA UDI
- Description
- Acu-Dispo-Curette 1mm cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814105020002 EUDAMED10814105020019 EUDAMED50814105020055 EUDAMED10814105020033 EUDAMED20814105020009 EUDAMED30814105020013 EUDAMED40814105020058 EUDAMED20814105020054 EUDAMED10814105020026 EUDAMED40814105020003 EUDAMED20814105020047 EUDAMED20814105020016 EUDAMED30814105020051 EUDAMED40814105020027 EUDAMED00814105020005 FDA UDI
- Basic UDI-DI
- B-10814105020002 EUDAMEDB-10814105020019 EUDAMEDB-50814105020055 EUDAMEDB-10814105020033 EUDAMEDB-20814105020009 EUDAMEDB-30814105020013 EUDAMEDB-40814105020058 EUDAMEDB-20814105020054 EUDAMEDB-10814105020026 EUDAMEDB-40814105020003 EUDAMEDB-20814105020047 EUDAMEDB-20814105020016 EUDAMEDB-30814105020051 EUDAMEDB-40814105020027 EUDAMED
- 510(k) Number
- K891334 FDA UDI
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- A01020303 CUTANEOUS BIOPSY CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Dermal curette, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermal curette, single-use
Acu-Dispo-Curette by Acuderm, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dermal curette, single-use.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acuderm, Inc.
Sources (15)
- FDA UDI b368a300-e0e1-4816-95fc-367f92d2aa1f 34 fields · synced Aug 4, 2026
- EUDAMED 82d81843-6026-4432-9bce-484afad7dfa5 61 fields · synced Jul 9, 2026
- EUDAMED 1d9028ca-a2dd-4ded-820b-e47bc23a0756 61 fields · synced Jul 9, 2026
- EUDAMED 9991447e-fb4e-4436-8618-e663796bfc00 61 fields · synced Jul 9, 2026
- EUDAMED 6d0ad991-7212-4a2f-a52c-df2e981d5a30 61 fields · synced Jul 9, 2026
- EUDAMED 2c0dbdc4-b00c-49e1-a2f8-edee4722eef0 61 fields · synced Jul 10, 2026
- EUDAMED e90c342a-d5b1-4372-b7ca-0231ccbb75b2 61 fields · synced Jul 10, 2026
- EUDAMED e03b339d-3c71-40a8-8a85-8249c2a7a230 61 fields · synced Jul 10, 2026
- EUDAMED 908211a0-ce85-4941-ab28-c95fae1251ef 61 fields · synced Jul 16, 2026
- EUDAMED 1a0b003a-6535-4847-82ee-1e62320d3f09 61 fields · synced Jul 20, 2026
- EUDAMED 4b4d6fe0-20cf-4901-b8d0-5adec833fdbe 61 fields · synced Jul 24, 2026
- EUDAMED 669a0732-90fe-435e-953c-3601c44c5b3e 61 fields · synced Jul 27, 2026
- EUDAMED 65a16ff0-8b77-4383-8c83-5fbd229cb675 61 fields · synced Jul 28, 2026
- EUDAMED f585dc58-88a1-4f3c-8ba0-e531b9135a75 61 fields · synced Aug 2, 2026
- EUDAMED b3d571a6-6eea-4f5c-9b99-875f27278aa0 61 fields · synced Aug 4, 2026