FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E-PACK
DI: 10705031009486
·
Model: 7395E
·
ETHICON INC.
Product Codes
7
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E-PACK
- Primary DI
- 10705031009486
- Version / Model
- 7395E
- Catalog Number
- 7395E
- Company Name
- ETHICON INC.
- Labeler DUNS
- 002144145
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 6
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 02ae3c9e-f7b3-43b6-9b5e-3ec4deb81a2e
- Distribution End Date
- 2019-08-19
Device Description
E-Pack Kits
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| GAQ | Suture, nonabsorbable, steel, monofilament and multifilament, sterile | General, Plastic Surgery | 878.4495 | 2 |
| GAN | SUTURE, ABSORBABLE, SYNTHETIC | General, Plastic Surgery | 878.4830 | 2 |
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
| FZP | CLIP, IMPLANTABLE | General, Plastic Surgery | 878.4300 | 2 |
| LDF | ELECTRODE, PACEMAKER, TEMPORARY | Cardiovascular | 870.3680 | 2 |
| GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | General, Plastic Surgery | 878.5010 | 2 |
| GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | General, Plastic Surgery | 878.4493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33961 | General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705031009486 | GS1 | ||||
| Package | 20705031009483 | GS1 | BOX | 5 | Not in Commercial Distribution | 2019-08-19 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from moisture and direct heat
- Type
- Storage Environment Temperature
- Temperature Range
- High: 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius