FDA UDI
In Commercial Distribution
🇺🇸 United States
PURIST
DI: 03701091006342
·
Model: 6813048B
·
ADSM
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PURIST
- Primary DI
- 03701091006342
- Version / Model
- 6813048B
- Catalog Number
- 6813048B
- Company Name
- ADSM
- Labeler DUNS
- 266749350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- 1590d035-1757-42ae-b27f-6c5a67850a62
Device Description
OLH #ERDP - B
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 Safe
- 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 |
|---|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42308 | Operating table orthopaedic extension | An orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701091006342 | GS1 |
Customer Contacts
- Phone
- +33428710310
- [email protected]
- Phone
- +1 409-658-1017
- [email protected]