FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Pin Applicator
DI: 06438394002319
·
Model: B-DIP-1500
·
Bioretec Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Pin Applicator
- Primary DI
- 06438394002319
- Version / Model
- B-DIP-1500
- Catalog Number
- B-DIP-1500
- Company Name
- Bioretec Oy
- Labeler DUNS
- 368715301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- 4a8fd8db-6604-4113-8e49-561557ef5fe9
Device Description
Applicator with K-wire Ø1.6 mm, disposable, for 1.5 mm pins
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438394002319 | GS1 | ||||
| Previous | E302BDIP15009 | HIBCC |
Customer Contacts
- Phone
- +358207789500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080879 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.5 | Millimeter |