FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiMac
DI: D105SKUMIR05CS0
·
Model: MIR05-CS
·
Surgimac LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SurgiMac
- Primary DI
- D105SKUMIR05CS0
- Version / Model
- MIR05-CS
- Catalog Number
- MIR05-CS
- Company Name
- Surgimac LLC
- Labeler DUNS
- 060635048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-22
- Public Version
- 1
- Public Version Date
- 2024-04-30
- Public Version Status
- New
- Public Device Record Key
- dfd61cda-62a0-45c1-bdeb-5281fce52023
Device Description
#5 Mirrors, Cone Socket F/S, 12/PK.
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
- No
- 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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D105SKUMIR05CS1 | HIBCC | Case | 100 | In Commercial Distribution | |
| Primary | D105SKUMIR05CS0 | HIBCC |