FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651293296
·
Model: 29329
·
O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651293296
- Version / Model
- 29329
- Catalog Number
- 29329
- Company Name
- O&M HALYARD, INC.
- Labeler DUNS
- 081057389
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 5
- Public Version Date
- 2019-11-20
- Public Version Status
- Update
- Public Device Record Key
- c2a07ebe-9486-4d51-8fc1-3fc4ad1259fd
- Distribution End Date
- 2019-11-19
Device Description
HALYARD* Banded Bag Equipment Cover
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47782 | Patient surgical drape, single-use, non-sterile | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651293290 | GS1 | CS | 25 | Not in Commercial Distribution | 2019-11-19 |
| Primary | 10680651293296 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]