FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046964656019
·
Model: 1050079A
·
B BRAUN SURGICAL SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046964656019
- Version / Model
- 1050079A
- Catalog Number
- 1050079A
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 3
- Public Version Date
- 2022-02-28
- Public Version Status
- Update
- Public Device Record Key
- 26ce758d-2110-40d0-a67e-fedd52b1cc73
- Distribution End Date
- 2022-02-24
Device Description
HISTOACRYL TIP PACK 10 UNITS
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MPN | Tissue adhesive for the topical approximation of skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58779 | Dermal surgical adhesive/sealant applicator | A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964656019 | GS1 | ||||
| Unit of Use | 04046964604874 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]