Identity
- Trade Name
- RetroFit Assortment Kit FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Model / Reference
- 5301 FDA UDI
Identifiers
- Catalog Number
- 1-535-5301GEF FDA UDI
- Primary DI / UDI-DI
- 00841912105076 FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile FDA UDI
Classification
- 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
Yes
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
Yes
FDA UDI
Category: Needle guide, single-useCable/lead/sensor/probe cover, sterile
RetroFit Assortment Kit by Protek Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI ed92cfbe-8240-4a14-a681-c8c9441d4b38 33 fields · synced Jun 6, 2026