Identity
- Trade Name
- Depth Gauge FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Depth Gauge, for D=0.9mm Guide Wire FDA UDI
- Model / Reference
- 59029 FDA UDI
- Description
- Depth Gauge, for D=0.9mm Guide Wire FDA UDI
Identifiers
- Catalog Number
- 59029 FDA UDI
- Primary DI / UDI-DI
- 09120047300855 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical depth gauge, reusable
Depth Gauge by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Redapt — Smith & Nephew, Inc. · Class II
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
- I.T.S. GmbH
Sources (1)
- FDA UDI c0190a2c-815e-47bb-b913-f3b93de56383 34 fields · synced Jun 8, 2026