FDA UDI
In Commercial Distribution
🇺🇸 United States
Socket Attachment Block block Ø 148 mm
DI: 04048817378765
·
Model: 12A5
·
Streifeneder ortho.production GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Socket Attachment Block block Ø 148 mm
- Primary DI
- 04048817378765
- Version / Model
- 12A5
- Catalog Number
- 12A5
- Company Name
- Streifeneder ortho.production GmbH
- Labeler DUNS
- 317931954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-15
- Public Version
- 2
- Public Version Date
- 2020-11-05
- Public Version Status
- Update
- Public Device Record Key
- c9a6d736-07d0-4318-992a-7593c41222cb
Device Description
Socket Attachment Block with poplar wood, block: Ø 148 mm, height: 65 mm, max. patient weight 125 kg
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISY | Joint, Knee, External Limb Component | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61229 | External lower-limb prosthesis structural/alignment component | A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048817378765 | GS1 |