FDA UDI
In Commercial Distribution
🇺🇸 United States
PANGEA
DI: 07613327603408
·
Model: 541400S
·
Stryker GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PANGEA
- Primary DI
- 07613327603408
- Version / Model
- 541400S
- Catalog Number
- 541400S
- Company Name
- Stryker GmbH
- Labeler DUNS
- 481999654
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-01
- Public Version
- 6
- Public Version Date
- 2026-04-01
- Public Version Status
- Update
- Public Device Record Key
- 7e67a705-f7eb-40ef-8a0c-2a0deaf4a6b0
Device Description
Cable Plug
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66933 | Orthopaedic bone cerclage wire | An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327603408 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Screw Head: 15.0 Torx | ||
| Device Size Text, specify | Diameter: 3.5 Millimeter |