FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 10612479246437
·
Model: 102-SN3C22105S3
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 10612479246437
- Version / Model
- 102-SN3C22105S3
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-19
- Public Version
- 1
- Public Version Date
- 2019-11-27
- Public Version Status
- New
- Public Device Record Key
- 6b43fcbf-4646-40cb-9841-a0a05b37104e
Device Description
Syringes with Safety Hypodermic Needles 3cc 22G x 1 1/2 in (100/bx, 4/cs)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40612479246452 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 20612479246441 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 10612479246437 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113422 | 000 |