Identity
- Trade Name
- STM 2000 PM Kit FDA UDI
- Generic Name
- Surgical instrument seal/seal maintenance set FDA UDI
- Device Name
- Preventative Maintenance Kit FDA UDI
- Model / Reference
- PM1005 FDA UDI
- Description
- Preventative Maintenance Kit FDA UDI
Identifiers
- Catalog Number
- PM1005 FDA UDI
- Primary DI / UDI-DI
- 10862675000337 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Surgical instrument seal/seal maintenance set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Surgical instrument seal/seal maintenance set
STM 2000 PM Kit by Skyline Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument seal/seal maintenance set.
- INTELIJET — Smith & Nephew, Inc. · Class I
- IMTEC — Park Dental Research Corp · Class I
- IMTEC — Park Dental Research Corp · Class I
- O-RING HEMORRHOID BAND CUTTER — SONTEC INSTRUMENTS, INC. · Class I
- E-LINE — Richard Wolf GmbH · Class II
- NON-LATEX O-RINGS — SONTEC INSTRUMENTS, INC. · Class I
- Park Dental Research Corp — Park Dental Research Corp · Class I
- Park Dental Research Corp. — Park Dental Research Corp · Class I
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skyline Medical Inc.
Sources (1)
- FDA UDI 5a1505dc-9cfb-416d-8a9a-717809fb639d 34 fields · synced May 30, 2026