FDA UDI
In Commercial Distribution
🇺🇸 United States
SPROTTE®
DI: 04048223127995
·
Model: 161151-29A
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SPROTTE®
- Primary DI
- 04048223127995
- Version / Model
- 161151-29A
- Catalog Number
- 161151-29A
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 2
- Public Version Date
- 2025-06-26
- Public Version Status
- Update
- Public Device Record Key
- 4e161237-6834-4657-b59d-c5182b845aee
Device Description
SPROTTE® 25G x 4" (103mm) with magnification and Introducer, sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35212 | Spinal needle, single-use | A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04048223129883 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04048223127995 | GS1 | ||||
| Previous | 04048223063859 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 103.0 | Millimeter | |
| Outer Diameter | 0.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius