Identity
- Trade Name
- SOFT-JECT® FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 10ML (12ML) SOFT-JECT® LUER LOCK BK 1,20X40MM/18GX1 1/2" FDA UDI
- Model / Reference
- 8300016322 FDA UDI
- Description
- 10ML (12ML) SOFT-JECT® LUER LOCK BK 1,20X40MM/18GX1 1/2" FDA UDI
Identifiers
- Catalog Number
- 8300016322 FDA UDI
- Primary DI / UDI-DI
- 04035873037804 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: General-purpose syringe, single-use
Soft-Ject® by Henke-Sass, Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SURGYCO — Surgyco LLC · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (1)
- FDA UDI 7eeadaf4-1cab-410f-80c3-f1178ada1449 36 fields · synced May 30, 2026