FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040184810
·
Model: 5703772
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
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Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040184810
- Version / Model
- 5703772
- Catalog Number
- 5703772
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 1
- Public Version Date
- 2024-08-23
- Public Version Status
- New
- Public Device Record Key
- 40965f73-bbb8-472c-bf59-9983c3fc58b7
Device Description
Cotton Ball Non-Sterile_large
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EFN | COTTON, ROLL | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34090 | Spring-loaded pneumoperitoneum needle, reprocessed | A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation (e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040184813 | GS1 | ||||
| Primary | 10304040184810 | GS1 |