FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04042409098635
·
Model: IC 0005-00
·
aap Implantate AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04042409098635
- Version / Model
- IC 0005-00
- Company Name
- aap Implantate AG
- Labeler DUNS
- 328420633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-28
- Public Version
- 1
- Public Version Date
- 2018-04-02
- Public Version Status
- New
- Public Device Record Key
- 39c6b8ec-7ecf-4a54-bb75-6dc73b7b0bde
Device Description
Staple for washers
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FSM | TRAY, SURGICAL, INSTRUMENT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10904 | Surgical instrument clip | A device designed to hold surgical instruments together; typically those with ring handles. This can be for sterilization, storage purposes, and/or to keep surgical instruments used for a particular procedure together prior to being lain out for surgery. It is typically designed like a very large safety pin (i.e., an elongated spring wire clasp with a locking catch onto which the instruments are threaded, usually by the ring handle). It is typically made of stainless steel or chromed metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04042409098635 | GS1 |