FDA UDI
In Commercial Distribution
🇺🇸 United States
Budde®
DI: 10381780537786
·
Model: 438A1154E
·
INTEGRA LIFESCIENCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Budde®
- Primary DI
- 10381780537786
- Version / Model
- 438A1154E
- Catalog Number
- 438A1154E
- Company Name
- INTEGRA LIFESCIENCES CORPORATION
- Labeler DUNS
- 963856096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-28
- Public Version
- 1
- Public Version Date
- 2024-07-08
- Public Version Status
- New
- Public Device Record Key
- c904ab17-c746-4d53-a823-adb6d1eb4505
Device Description
Budde® 5/16" – 1" x 5" Tapered
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 10381780537786 | GS1 | ||||
| Previous | 10381780253228 | 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 | 10" Length x 6" Width x 0.05" Height |