FDA UDI
In Commercial Distribution
🇺🇸 United States
Etac Supply Center AB
DI: 07320450002397
·
Model: Uni
·
Etac Supply Center AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Etac Supply Center AB
- Primary DI
- 07320450002397
- Version / Model
- Uni
- Catalog Number
- 80503003
- Company Name
- Etac Supply Center AB
- Labeler DUNS
- 354870610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- ddf61b7d-60b7-46f6-91f9-e68b0cd36c29
Device Description
Turner
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
- No
- 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 |
|---|---|---|---|---|
| IKW | UTENSIL, HOMEMAKING | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64363 | Assistive gripping/twisting tool, reusable | A hand-held manual device intended to be used to grip and/or twist medical device and/or household items, usually to lock/unlock, turn on and off, and/or open and close components. It may or may not be intended to be a disability-assistive tool and it might have one or more gripping component(s) or spanner-like ends, and a lever or dial for twisting/turning. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07320450002397 | GS1 |