Identity
- Trade Name
- BOSS Instruments FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- Kray Hk w/finger rest, 7 1/4", sm blnt FDA UDI
- Model / Reference
- 71-6100 FDA UDI
- Description
- Kray Hk w/finger rest, 7 1/4", sm blnt FDA UDI
Identifiers
- Catalog Number
- 71-6100 FDA UDI
- Primary DI / UDI-DI
- 00888515172098 FDA UDI
- FDA Product Code
- GZX FDA UDI
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4525 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery dissector
BOSS Instruments by Boss Instruments, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery dissector.
- Kamiyama — TAKAYAMA INSTRUMENTS INC. · Class I
- KEYSTONE — Depuy Spine, Inc. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Wiggins Medical — EBNER MEDICAL LLC · Class I
- Fisch dissector — Spiggle & Theis Medizintechnik GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · 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
- Boss Instruments, Ltd.
Sources (1)
- FDA UDI 857adead-5fa4-4e88-9942-d97167bd427f 35 fields · synced Jun 9, 2026