FDA UDI
In Commercial Distribution
🇺🇸 United States
Budde®
DI: 10381780253495
·
Model: A1096P
·
INTEGRA LIFESCIENCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Budde®
- Primary DI
- 10381780253495
- Version / Model
- A1096P
- Company Name
- INTEGRA LIFESCIENCES CORPORATION
- Labeler DUNS
- 963856096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-26
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 92bd90be-cc03-4b98-bb94-b06acf90ff22
Device Description
The BUDDE® Halo Retractor Systems are designed to provide a stable framework surrounding the operative site for the purposes of retracting delicate brain tissue during neurosurgical procedures. The BUDDE® Systems consist of an adjustable halo ring that rigidly attaches to a MAYFIELD® Skull Clamp or surgical table, flexible retractor arms, and various retractor blades and patty trays
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZT | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY | Neurology | 882.4800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62772 | Neurosurgical retraction system, brain | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M268A1096P1 | HIBCC | ||||
| Primary | 10381780253495 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K830332 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 23" Length x 13.1" Width x 3.8" Height |