Identity
- Trade Name
- STEINMANN PIN PACKAGE FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- STEINMANN PIN PACKAGE OF 6 DOUBLE ENDED SMOOTH TROCAR TIP FDA UDI
- Model / Reference
- 1106-500 FDA UDI
- Description
- STEINMANN PIN PACKAGE OF 6 DOUBLE ENDED SMOOTH TROCAR TIP FDA UDI
Identifiers
- Catalog Number
- 1106-500 FDA UDI
- Primary DI / UDI-DI
- 00192896097636 FDA UDI
- 510(k) Number
- K100736 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Length — 9 Inch FDA UDI
Category: Orthopaedic trocar blade, reusable
Steinmann Pin Package by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic trocar blade, reusable.
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Cleared under the same submission
K100736 also covers:
- Batrik K-Wire & Steinman Pins — Batrik Medical Manufacturing Inc
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 01b9682f-20f4-4857-8011-86d2ae1049c7 37 fields · synced Jun 1, 2026