FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00614950013517
·
Model: 0031402
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- ACE
- Primary DI
- 00614950013517
- Version / Model
- 0031402
- Catalog Number
- 0031402
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-10-16
- Public Version
- 1
- Public Version Date
- 2019-10-24
- Public Version Status
- New
- Public Device Record Key
- 17d3f112-6838-4fc5-ab82-6d00c139e54c
Device Description
ACE IRRIGATION SET 67" STERILE L/F 50/CA
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPK | Tubing, fluid delivery | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64257 | Surgical instrument irrigation channel | A length of invasive flexible or semi-flexible tube designed to be attached to a surgical instrument (e.g., surgical stapler) to direct irrigation fluids to the surgical site; it may in addition be intended to allow for introduction of air to facilitate procedures such as staple line leak testing, however it is not intended for medical gas insufflation or suction. It is intended to be used in combination with devices that do not have an integrated irrigation channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950013517 | GS1 | ||||
| Unit of Use | 10614950013514 | GS1 |
Customer Contacts
- Phone
- +1(508)588-3100 ext. 214
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 67 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required