FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuForm™ Shim
DI: 00841439113585
·
Model: MTACLSHIM
·
MEDTEC, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AccuForm™ Shim
- Primary DI
- 00841439113585
- Version / Model
- MTACLSHIM
- Catalog Number
- MTACLSHIM
- Company Name
- MEDTEC, INC.
- Labeler DUNS
- 103977526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-16
- Public Version
- 2
- Public Version Date
- 2022-08-11
- Public Version Status
- Update
- Public Device Record Key
- 2df1533c-2673-45ac-8f81-1c0f30a814ed
Device Description
AccuForm™ Shim
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
| IXQ | Table, radiographic, stationary top | Radiology | 892.1980 | 2 |
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40894 | Patient positioning foam mould kit | A collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould of that anatomy. The mould can be whole body or only selected body parts and are commonly used to help ensure adequate positioning and immobilization of the patient during radiation therapy treatments and to facilitate reproducible positioning for serial treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841439113582 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00841439113585 | GS1 |
Customer Contacts
- Phone
- +1(712)737-8688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180021 | 000 |