FDA UDI
In Commercial Distribution
🇺🇸 United States
P&P Medical Surgical LLC
DI: G026090001
·
Model: 09000
·
P&P Medical Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- P&P Medical Surgical LLC
- Primary DI
- G026090001
- Version / Model
- 09000
- Company Name
- P&P Medical Surgical LLC
- Labeler DUNS
- 022925151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-11
- Public Version
- 1
- Public Version Date
- 2022-02-21
- Public Version Status
- New
- Public Device Record Key
- 4893b227-a961-4170-b95b-ddade934c543
Device Description
Tongue Depressors Non Sterile Non Splinter Chemical Free Wooden 6 inch High Grade Natural Birch Box of 100
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | 880.6230 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42461 | Tongue depressor, examination, single-use | A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G026090001 | HIBCC |