Identity
- Trade Name
- IBS-B FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Drill for screwsDia.3.3mm, Non-Sterile FDA UDI
- Model / Reference
- G01 N0071 FDA UDI
- Description
- Drill for screwsDia.3.3mm, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- G01 N0071 FDA UDI
- Primary DI / UDI-DI
- 00810021867793 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Orthopaedic bur, reusable
Ibs-B by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bur, reusable.
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Midas Rex Clearview™ — MEDTRONIC XOMED, INC. · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · 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 |
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Manufacturer
- Manufacturer
- In2Bones, USA
Sources (1)
- FDA UDI 4ee31adc-7fed-4891-bed3-845396bf8c57 35 fields · synced May 30, 2026