FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 00612479205376
·
Model: 16-1103
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- McKesson
- Primary DI
- 00612479205376
- Version / Model
- 16-1103
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-08-26
- Public Version
- 1
- Public Version Date
- 2021-09-03
- Public Version Status
- New
- Public Device Record Key
- 3b008154-5eb7-4edf-89bc-141cec3e3021
Device Description
Exam Shorts NON-WOVEN | BLUE x-Large (25/bg, 4/cs)
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
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63872 | Surgical patient underpants | A pair of underpants/shorts made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by a patient for comfort, covering, and a degree of warmth before, during, and/or after a surgical intervention; it may have an opening(s) to allow access to body orifices. It is not specifically intended for support, and is typically loose fitting to accommodate a variety of sizes; it does not include antimicrobial properties. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00612479106185 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00612479205376 | GS1 | ||||
| Unit of Use | 00612479236509 | GS1 |