FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MABIS DMI
DI: 00041298400103
·
Model: 650-4001-0000
·
D-M-S HOLDINGS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MABIS DMI
- Primary DI
- 00041298400103
- Version / Model
- 650-4001-0000
- Catalog Number
- 650-4001-0000
- Company Name
- D-M-S HOLDINGS, INC.
- Labeler DUNS
- 062028220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-09-22
- Public Version Status
- Update
- Public Device Record Key
- 7b41f114-4403-47dd-866f-c92b0a37e0c8
- Distribution End Date
- 2022-09-21
Device Description
OB KIT - STANDARD WITH STERILE SCAPEL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60644 | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041298400100 | GS1 | Master Carton | 20 | Not in Commercial Distribution | 2022-09-21 |
| Primary | 00041298400103 | GS1 |