FDA UDI
In Commercial Distribution
🇺🇸 United States
ACE
DI: 00614950021925
·
Model: 0531016
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACE
- Primary DI
- 00614950021925
- Version / Model
- 0531016
- Catalog Number
- 0531016
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-19
- Public Version
- 1
- Public Version Date
- 2019-10-28
- Public Version Status
- New
- Public Device Record Key
- 17c2d498-89f9-4ef3-ac19-8342335ae2af
Device Description
JAR DRESSING 4-1/2QT STAINLESS STEEL 7"X7-3/8"
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10171 | Applicator jar | A cylindrical vessel designed for holding various types of applicators (e.g., swabs, towelettes) in a clean container to reduce the possibility of contamination and to be ready for use. It is typically made of high-grade stainless steel, glass, or less frequently sterilizable plastic material (e.g., polypropylene). It will have a wide or weighted base to give it stability and a tightly sealed cover (lid). It is frequently used in ear/nose/throat (ENT) procedures, as well as procedures on the eyes, or the vagina and used in, e.g., an examination room, a doctor's surgery, or the sterile field during a surgical intervention. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614950021925 | GS1 |
Customer Contacts
- Phone
- +1(800)441-3100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7.375 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required