Identity
- Trade Name
- Surgical HypoHolder FDA UDI
- Generic Name
- Needle recapping device, reusable FDA UDI
- Device Name
- Magnetic pin and handle base FDA UDI
- Model / Reference
- 1003 FDA UDI
- Description
- Magnetic pin and handle base FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010987902 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Needle recapping device, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Needle recapping device, reusable
Surgical HypoHolder by Tytek Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle recapping device, reusable.
- Jenker — Dentsply Professional · Class I
- NopoGuard — DENTAL PRODUCTS LAB · Class I
- CONTA-GUARD — Rønvig Dental Manufacturing A/S · Class I
- NopoGuard — DENTAL PRODUCTS LAB · Class I
- NeedleSafe — Ingenious Technologies Corp. · Class II
- Clinical HypoHolder — TYTEK MEDICAL INC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tytek Medical Inc
Sources (1)
- FDA UDI 6e2b299d-d432-4a0b-922b-e1dfd127786e 33 fields · synced Jun 8, 2026