FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046963320386
·
Model: FR736
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046963320386
- Version / Model
- FR736
- Catalog Number
- FR736
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 10
- Public Version Date
- 2025-10-29
- Public Version Status
- Update
- Public Device Record Key
- 5be286ac-7109-4b26-b5ee-d4ed51736c05
- Distribution End Date
- 2025-10-28
Device Description
RESORBABLE PIN F/SCAFFOLD FIXATION (3X)
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
- No
- 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 |
|---|---|---|---|---|
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45037 | Orthopaedic bone pin, bioabsorbable | A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963320386 | GS1 | ||||
| Unit of Use | 04046963092207 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 38 – 38 Degrees Celsius